Product Description
Most pacifier product lines address different developmental stages by launching separate SKUs — a 0–6m style, a 6–18m style, a teething-specific variant. Each SKU requires its own mold, separate compliance testing, and distinct retail presentation. For a brand managing a pacifier category with limited SKU slots, or for a wholesale buyer building a catalog with minimal initial tooling investment, this approach creates duplicated costs without always creating genuine consumer differentiation.
The Round Pacifier SP-1138 solves this with a 3-Teat Modular System: a single circular PP-shield base that supports three distinct nipple head geometries, each optimized for a specific developmental stage. The three teat styles are not interchangeable by the end consumer during daily use — each variant ships as a complete assembled unit — but from a brand and SKU architecture perspective, the three heads share a single shield mold, a single compliance documentation dossier, and a single product family identity. One OEM program covers three use-case positions.
The three teat styles and their development contexts:
The Round head is the SP-1138's entry configuration: a smooth, symmetrical circular nipple body calibrated for infants from birth through six months. The round nipple geometry produces a concentric sucking load — the infant's lips seal uniformly around the nipple's circular cross-section, generating a stable, repeating peristaltic suction pattern. For the 0–6m cohort, this is the appropriate geometry: the jaw has developed to accept a round nipple comfortably, and the smooth surface is the most familiar and lowest-stimulation option for younger infants.
The Round head is available in two weight presentations: a transparent day-use version (8.4g) — the lightest configuration in the SP-1138 family — and the same geometry adapted for nighttime use. At 8.4g total product weight, the jaw-loading moment in a supine infant is minimal, supporting prolonged sleep-time pacifier retention without muscular fatigue. The round head is the recommended starting point for a brand entering the SP-1138 system, and the default SKU for buyers seeking a clean, category-standard pacifier without developmental-stage text on the packaging.
The Strawberry head introduces a textured surface to the nipple body: a rounded bulb form with a fine raised-dot pattern across the contact surface, mimicking the skin of a strawberry. This is not purely an aesthetic feature. In the 6-month+ cohort, the alveolar ridges are actively firming in preparation for tooth eruption, and infants in this stage demonstrate a documented preference for objects that provide tactile feedback against the gums — a behavior commonly recognized as the oral exploration phase preceding and accompanying teething.
The Strawberry head's textured surface provides controlled mechanical stimulation to the gum surface during sucking. Each suck cycle presses the dot-pattern surface against the upper and lower alveolar ridges, delivering low-intensity contact that many parents and pediatric healthcare professionals describe as soothing during the teething period. The Strawberry head weighs 9.0g — marginally heavier than the Round head due to the increased surface detail in the nipple molding — still well within the ultra-light range for 6m+ infants whose jaw muscles have developed proportionally. For brand owners, the Strawberry head provides a product story that justifies a 6m+ SKU transition and supports retail merchandising around the teething category alongside teething rings and chew toys.
The Spiral head takes the SP-1138's 6m+ positioning in a different direction from the Strawberry head. Its nipple body is a ridged cylindrical column with spiral groove detailing running from base to tip — a geometry that serves two distinct functions. First, the column form allows a deeper oral insertion angle than the round bulb, placing the nipple tip in contact with the posterior palate and the lateral edges of the tongue's midline — a different oral zone from the anterior-contact geometry of the round or strawberry heads. This varied oral-zone stimulation addresses the 6m+ infant's increasingly active oral exploration behavior.
Second, the spiral grooves on the nipple surface create minor variations in suction resistance as the infant compresses the nipple during sucking. For infants who have developed stronger suction mechanics by 6 months and are beginning to reject the low-resistance experience of softer younger-stage pacifiers, the slight resistance variation of the spiral geometry provides a more engaging suction experience. The Spiral head is the heaviest SP-1138 variant at 9.4g, reflecting the increased material volume of the column-form nipple body. For brand owners, the Spiral head is the most visually distinctive option in the SP-1138 system — its ridged column geometry photographs differently from any competitor's standard pacifier, providing strong product imagery differentiation.
The Round Pacifier's construction separates material responsibility between the two components that perform different physical functions in daily use. The PP (polypropylene) shield provides structural integrity: the circular disc that presses against the infant's face and prevents the nipple from being drawn fully into the mouth must maintain its shape under repeated compressive load from jaw pressure and against biting. PP achieves this requirement in a way that food-grade silicone cannot — silicone's elastomeric properties, which make it ideal for the nipple, mean that a full-silicone shield will flex and distort under load. Over weeks of daily use, a flexing silicone shield can develop stress marks and dimensional drift that affect both the EN 1400 shield-dimension compliance and the visual condition of the product at retail return assessment.
The SP-1138's PP shield maintains its circular geometry through the product's full recommended use life. This is not a material trade-off — it is a deliberate structural decision that gives the shield the dimensional stability needed to remain within EN 1400 shield-size tolerances throughout use. The three ventilation holes punched through the PP shield are dimensionally precise and maintain their circular geometry without the oval distortion that occurs in silicone shields under consistent face-pressing load.
The food-grade silicone nipple — manufactured under Invention Patent CN114015239A — retains all the tactile and safety advantages of silicone: soft against the infant's mucous membranes, thermally stable across all household sterilization methods, with material migration limits independently verified against EN 1400 thresholds by accredited third-party laboratory. Shore A hardness is specified for each of the three teat styles to match the intended developmental stage — the Round head's softer specification for 0–6m infants, and a marginally firmer specification for the Strawberry and Spiral heads' 6m+ target cohort.
The three ventilation holes punched through the SP-1138's PP shield serve two distinct safety functions, both relevant to EN 1400 compliance and one relevant to the EU's pacifier safety regulation's specific choking-hazard provisions.
Saliva drainage and skin hygiene: Pacifier shields that seal completely against the face create a microclimate of trapped saliva and moisture between the shield and the perioral skin. In infants — particularly those with sensitive skin — this moisture environment elevates the risk of perioral contact dermatitis and miliaria. The three ventilation holes in the SP-1138 shield allow airflow across the contact area, reducing moisture accumulation and maintaining the perioral skin environment. This is a documented clinical benefit cited by pediatric dermatology guidance in the EU and the US.
EN 1400 ventilation provision: The EN 1400 standard (Clause 5.5) specifies requirements for shield ventilation in pacifiers — minimum hole sizes and placement designed to ensure that, in the unlikely event that a pacifier is drawn fully into the oral cavity of a distressed infant, the ventilation openings allow sufficient air exchange to prevent asphyxiation while a carer removes the pacifier. The SP-1138's three ventilation holes are dimensioned and positioned to satisfy EN 1400 Clause 5.5 requirements, as verified in the third-party test report issued by an accredited laboratory. For buyers, this means the ventilation holes are not aesthetic — they are part of the EN 1400-compliant safety architecture of the product, and their presence should be referenced in product safety documentation.
The SP-1138's shield includes an integrated ring handle: a small circular loop molded directly into the PP shield body, positioned at the bottom center of the disc. This is a one-piece construction — the ring and shield are a single molded component with no joint, weld, or adhesive interface — which means there is no failure mode associated with the ring detaching from the shield under pull force.
EN 1400 Part 2 (physical and mechanical properties) includes a pull-force test that applies a defined load to any protrusion, handle, or attachment point on a pacifier to confirm that it cannot be separated from the shield under foreseeable use conditions. Because the SP-1138's ring handle is an integrally molded feature of the PP shield, it passes the EN 1400 pull-force test with margin — verified in the third-party test documentation. This matters for buyers who package the SP-1138 with compatible pacifier clips or holder chains: the ring handle provides a clean, standardized attachment point for pacifier clips, enabling EN 1400-compliant accessory integration without additional hardware. The ring also serves as the hook point for sterilization basket or boiling pot retrieval — practical functionality that pediatric nurses and parents cite positively in product feedback for similar round-shield designs.
The silicone nipple across all three SP-1138 teat styles is manufactured from Mitour's proprietary infant-grade compound protected by Chinese Invention Patent CN114015239A. This is a silicone formulation engineered specifically for products in sustained contact with infant mucous membranes — a surface class with stricter biological safety requirements than standard food-contact silicone applications.
The CN114015239A compound achieves three parameters standard food-grade silicone is not required to meet: (1) material migration limits tighter than EN 1400 thresholds, independently verified through third-party laboratory testing and included in the EN 1400 test dossier; (2) Shore A hardness range calibrated for the infant suckling reflex — firm enough to maintain nipple geometry against bite load, soft enough to minimize jaw fatigue across the relevant age band; (3) full thermal stability across boiling water (100°C), steam sterilizer (134°C), and UV-C sterilizer cycles without physical degradation or migration exceedance. Because CN114015239A is a registered Invention Patent — China's highest patent grade — it is independently verifiable through the CNIPA database and can be cited in EU Technical Files, CPSC compliance records, and product safety dossiers. This provides a compliance evidence layer beyond standard material certifications.
The SP-1138 is configured around six standard twin-color combinations — each pairing a shield color with a contrasting or complementary nipple silicone color — validated for EN 71-3 heavy-metal migration compliance and ready to produce at MOQ 300 pcs without additional color testing investment:
# | Shield Color | Nipple Color | Primary Use Context |
1 | Light Pink | Light Blue | Mixed-gender gifting, gender-reveal gift sets |
2 | Bright Red | Light Pink | High-visibility retail shelf; bold color SKU |
3 | Light Blue | Light Pink | Mixed-gender; boy-skewed first read |
4 | Cream | Light Blue | Neutral/premium aesthetic; boutique positioning |
5 | Transparent | Bean Green | Night-use designation (transparent shields read as "clear/clean" in low light) |
6 | Transparent | Khaki | Day-use designation; natural/understated aesthetic |
The transparent shield variants (combinations 5 and 6) serve a secondary function beyond color differentiation: the transparent PP construction allows caregivers to observe the nipple condition through the shield without removing the pacifier from the infant's mouth — a practical benefit that parents and clinical caregivers consistently cite. For retail merchandising, the six twin-color combinations create immediate visual variety on a peg hook or shelf bay without requiring a buyer to manage multiple product families. For Amazon listing management, the six combinations enable a parent-child ASIN structure with six color children, maximizing color-specific search term coverage.
The SP-1138 family's total product weight varies by teat style in a controlled, intentional range: 8.4g (Round head, transparent day-use), 9.0g (Strawberry head), and 9.4g (Spiral head). This incremental weight distribution is consistent with the developmental progression the three heads represent.
The Round head's 8.4g configuration is the lightest — appropriate for the 0–6m cohort where jaw-loading in supine infants is a clinical consideration. As the infant progresses to the Strawberry (6m+) and Spiral (6m+) heads, the marginally higher weights (9.0g and 9.4g respectively) are appropriate for a jaw musculature that has developed proportionally and can sustain slightly greater downward loading without fatigue. All three weight variants remain well below the 15–20g range typical of full-silicone or character-shield pacifiers that include larger hardware components, maintaining the SP-1138's ultra-light positioning across its entire product family. For buyers presenting technical data sheets to pediatric retailers or clinical procurement committees, the head-specific weight breakdown is available in Mitour's standard compliance documentation package.
Criteria | Mitour SP-1138 3-Teat Modular Round Pacifier | Conventional Single-Teat Pacifier |
Teat style options | 3 styles (Round / Strawberry / Spiral) on one shield platform | 1 style; separate SKU required for each developmental stage |
Developmental coverage | 0–6m (Round) + 6m+ (Strawberry, Spiral) — single platform | Typically one age band per SKU; separate product needed for progression |
SKU complexity for brand | 1 shield mold + 3 nipple variations — shared compliance dossier | 3× separate SKUs, 3× compliance packages, 3× tooling investments |
Teething-stage feature | Strawberry head — raised-dot gum massage texture | Not present (smooth nipple only) |
Advanced-suction feature | Spiral head — ridged column, varied resistance geometry | Not present |
Shield material | PP (polypropylene) — maintains dimensional stability under jaw load | Full silicone (can flex/deform under repeated compressive bite load) |
Shield shape retention | Dimensionally stable — EN 1400 shield-size compliance maintained across use life | May drift from EN 1400 tolerance under extended use |
Color configuration | 6 twin-color bicolor combos (shield + nipple contrast) | Typically single-color or 2-color shield only |
Ventilation holes | 3 holes — EN 1400 Clause 5.5 compliant | Varies; some designs have 2 holes or none |
Ring handle construction | Integrally molded PP ring — passes EN 1400 pull-force with margin | Clip-on or welded ring — potential joint failure under pull-force test |
Product weight | 8.4–9.4g (by head style) — ultra-light range | 14–22g typical for full-silicone round-shield designs |
Retail visual impact | Bicolor contrast — strong shelf differentiation | Often single-color; lower visual distinctiveness per peg hook |
MOQ | 300 pcs (= 1 standard master carton) | Often 500–1,000 pcs at comparable suppliers |
EN 1400 compliance | Full — shield dimensions, pull force, ventilation, migration — all certified | Varies by supplier |
Bottom line: For buyers who need a pacifier range that covers both the 0–6m and 6m+ developmental stages — including a stage-specific teething-texture option and a strong-suction variant — within a single OEM program, shared compliance documentation, and bicolor retail presentation, the SP-1138 3-Teat Modular System delivers a commercially complete answer that three separate single-teat SKUs could not replicate at comparable cost and lead time.
Item | Detail |
Model | SP-1138 |
Product Name | Round Pacifier — 3-Teat Modular System |
Overall Dimensions | 65 × 50 × 51 mm |
Material — Nipple | 100% Food-Grade Silicone, patented infant-grade formula (CN114015239A) |
Material — Shield | Food-grade PP (polypropylene) |
Shield Shape | Round (circular) |
Ventilation Holes | 3 holes (EN 1400 Clause 5.5 compliant) |
Handle | Integrated ring (integrally molded PP — no joint; passes EN 1400 pull-force test) |
Teat Style 1 — Round Head | Classic smooth round nipple; 0–6m; 8.4g (transparent day-use version) |
Teat Style 2 — Strawberry Head | Rounded bulb with raised-dot textured surface; 6m+; 9.0g |
Teat Style 3 — Spiral Head | Ridged column with spiral groove detailing; 6m+; 9.4g |
Age Range | 0–6m (Round head) / 6m+ (Strawberry and Spiral heads) |
Standard Twin-Color Combinations (6) | Light pink + light blue · Bright red + light pink · Light blue + light pink · Cream + light blue · Transparent + bean green (night) · Transparent + khaki (day) |
Custom Colors | Pantone matching available (min. 500 pcs per custom color combination) |
Logo Options | Roller print, silk screen, laser engraving, UV full-color, heat transfer, water transfer (6 methods) |
Packaging | Blister, color retail box, OPP bag — 2pcs / 4pcs per retail unit |
Master Carton | 500 × 350 × 350 mm · 4 kg · 300 pcs/carton |
MOQ | 300 pcs (= 1 master carton) |
Sample Lead Time | 7 business days |
Production Lead Time | 25–35 days after PO confirmation + deposit |
Certifications | EN 1400, ASTM F963, CPC/CPSIA, FDA, LFGB, EN 71 (incl. EN 71-3), BSCI, SEDEX, ISO 9001:2015, ISO 14001, ROHS, REACH |
Infant-Specific Standards | EN 1400 (EU pacifier), ASTM F963 (US), CPC/CPSIA (US retail + Amazon), EN 71-3 (heavy metal migration) |
Compliance Docs Provided | EN 1400 test report, ASTM F963 test report, CPC certificate, FDA material declaration, BPA/BPS/phthalate-free statement, REACH/ROHS declaration |
Factory Approvals | Walmart-approved (2019), Target-approved (2019), Disney-audited (2022) |
Trade Terms | EXW Shenzhen / FOB Shenzhen / CIF (by negotiation) |
Container Loading | 20' GP: ~150,000 pcs / 40' HQ: ~320,000 pcs (with standard retail packaging) |
Factory | Shenzhen Yuanfeng Xingye Technology Co., Ltd. · 4,500 m² · 100+ employees · 20+ machinery engineers |
Brand | Mitour Silicone / HAPBAY™ (EUIPO registered) |
Founded | 2005 (21 years of silicone manufacturing experience) |
For a brick-and-mortar baby specialty retailer, the SP-1138's three teat styles create a natural in-store upsell narrative: parents who purchase the Round head variant at the newborn stage return to the shelf at 6 months looking for a teething-compatible pacifier. With the Strawberry head and Spiral head variants positioned as the visible 6m+ continuations of the same family, the repeat purchase is framed as a stage progression — not a brand switch. The consistent PP shield shape, identical ring handle, and matching twin-color palette across all three head styles allow a retailer to merchandise the Round, Strawberry, and Spiral heads as a cohesive visual family on a single shelf bay, with stage-transition messaging ("Your next step at 6 months") built into the retail presentation. The six twin-color combinations provide enough visual variety to occupy a full peg-hook bay with color choice without requiring a buyer to stock multiple separate product lines.
Amazon's parent-child ASIN structure benefits directly from the SP-1138's modular architecture. A seller can build a single parent listing ("Round Pacifier — 3 Teat Styles") with child ASINs organized by teat style (Round, Strawberry, Spiral) and color variant (6 bicolor options × 3 teat styles = up to 18 child ASINs). The teat-style variation supports keyword targeting across multiple developmental-stage search terms: "newborn round pacifier," "teething pacifier 6 months," "baby pacifier with textured nipple," and "spiral nipple pacifier" can all be addressed within a single parent listing's title, bullets, and A+ content. The CPC certificate is included in Mitour's standard documentation for every production batch, eliminating the primary cause of Amazon pacifier listing approval delays. FNSKU labeling, polybag, and carton-level FBA preparation are available.
European importers supplying baby specialty chains, pharmacy retailers, and online baby marketplaces face the combined documentation requirement of EN 1400 (EU), LFGB (Germany-specific food-contact regulation for silicone), and EN 71-3 (colorant heavy metal migration). The SP-1138's dual-material construction — PP shield with silicone nipple — means each material component is tested against its relevant standard: PP structural properties under EN 1400 shield-dimension and pull-force clauses; silicone nipple compound under EN 1400 migration limits and LFGB food-contact provisions; colorants under EN 71-3. Mitour's standard compliance package covers all three material-specific test categories in a single documentation set, reissuable under the buyer's brand name. The six standard twin-color combinations are all EN 71-3 validated — no additional colorant testing cost for any of the six standard SKUs. For buyers entering the German, French, or Benelux markets, documentation in language-appropriate formats is available on request.
For brands that already sell a 0–6m round pacifier and are looking to reduce customer churn at the 6-month stage transition, the Strawberry and Spiral head variants of the SP-1138 provide a development-stage retention tool. A brand can run a CRM-triggered campaign — "Your baby is 6 months old: upgrade to the Strawberry or Spiral pacifier for teething comfort" — backed by a product that shares the same brand family identity as the original 0–6m purchase. The teething-texture narrative of the Strawberry head ("raised-dot surface for gum massage during tooth eruption") is a documented purchase motivator for parents in the 5–8 month age window, who are actively searching for teething-stage sensory products. The Spiral head's advanced-suction positioning serves infants who have rejected standard round pacifiers at 6m+ due to reduced suction resistance. Together, the two 6m+ teat styles enable a brand to address the two most common reasons parents switch pacifier brands at 6 months: teething discomfort and pacifier rejection.
The SP-1138's six twin-color combinations make it naturally suited to promotional gift set applications where visual presentation is a purchase driver. The bicolor contrast of shield-versus-nipple creates an inherently more gift-appropriate visual than a single-color pacifier. For baby shower gift sets, the light pink + light blue and cream + light blue combinations are gender-neutral without being bland. For twin baby programs, the light pink + light blue and light blue + light pink combination pairing offers an immediately legible "one for each" visual story within a two-pack. The 2pcs and 4pcs retail packaging formats align with standard gift-set configurations: a 2pcs pack as a standalone gift item and a 4pcs pack for gift set bundles that include a pacifier clip, sterilization case, or storage pouch. Co-packing of the SP-1138 with compatible Mitour accessories — silicone pacifier clip, travel sterilization case — is available as an add-on service.
Mitour operates a full in-house tooling workshop within its 4,500 m² Shenzhen facility. The SP-1138 modular platform supports both color and structural customization, with true ODM capability for new teat geometries.
Twin-Color Combination Customization
6 standard twin-color combinations available at MOQ 300 pcs total with no additional colorant testing cost
Custom Pantone color combinations: available at MOQ 500 pcs per custom combination; includes EN 71-3 colorant validation before production release
Transparent shield variants (combinations 5 and 6) available with any silicone color for the nipple
Full custom bicolor program: shield color + nipple color selected independently for maximum brand-palette alignment
Nipple/Teat Head Customization
Private-mold teat geometry: ODM new teat head shapes are supported within the SP-1138 shield platform; mold costs and lead times scoped per project
Shore A hardness adjustment for custom age-band positioning (e.g., extra-soft for 0–3m Round head, firmer for 9m+ Spiral head variants)
Antimicrobial treatment available under Invention Patents CN113650314A and CN114105598B for institutional supply programs or premium wellness positioning
Logo & Branding Methods (6 Options)
Roller print: continuous pattern print on shield — cost-effective for high-volume branding
Silk screen: precision flat-surface logo application on PP shield face
Laser engraving: recessed logo into PP shield — zero ink migration, durable premium finish
UV full-color printing: photographic-quality full-color on shield face — highest visual impact for lifestyle brand packaging
Heat transfer: complex or multi-color logo application across shield surface
Water transfer: texture or pattern transfer across the curved shield geometry
Packaging Options
Blister card (standard): clear front, printed back card; 2pcs or 4pcs configurations; FNSKU barcode placement available
Full-color retail box: CMYK + spot color + matte/gloss laminate; custom dieline supplied; window-cut format for nipple visibility
OPP bag + hangtag: lightweight market-stall or DTC format
Gift box with foam insert: for twin-pack or mixed-head-style gift sets
Custom shipper carton: artwork and logistics labeling; 300 pcs standard master carton
Compatible Accessory Co-Packing
Silicone pacifier clip / holder chain (EN 1400-compliant)
Travel sterilization case (compatible ring-handle diameter)
Individual dust covers (PP shield geometry-matched)
Teething gift set box (SP-1138 Strawberry or Spiral head + teething ring + clip)
Compliant with EN 1400 and ASTM F963 use and maintenance recommendations. For clinical guidance on infant pacifier use and teething management, consult a licensed pediatrician or certified pediatric dentist.
Before First Use — Sterilization
Boil in clean water for 5 minutes before first use. Hold the ring handle with sterilized tongs; do not grip the nipple or squeeze the shield during heating. Remove and place on a clean, dry surface. Allow to cool fully before checking the nipple: if any discoloration, stickiness, swelling, or surface irregularity is present, discard the unit before use. The PP shield will feel firm and maintain its shape after boiling — this is expected behavior from the dual-material construction.
Daily Cleaning
Rinse under warm running water immediately after each use. Use a drop of unscented baby-safe detergent and a soft infant brush for thorough cleaning. Pay specific attention to the three ventilation holes in the PP shield: use a thin-bristle brush or pipecleaner to clean the interior of each hole, as trapped saliva residue in the holes is a common oversight that reduces hygiene performance over time. Rinse thoroughly and air-dry on a clean rack with the nipple pointing downward to allow complete drainage from all surfaces.
Sterilization Methods — All Three Validated for the SP-1138 Dual-Material Construction
Boiling water: up to 5 minutes per cycle — validated for both the patented CN114015239A silicone nipple compound and the PP shield. The PP shield material is rated for boiling temperature without dimensional deformation.
Steam sterilizer (electric or microwave): follow the sterilizer manufacturer's instructions; both the silicone nipple and the PP shield withstand standard steam sterilization cycles without material degradation.
UV-C sterilizer: fully compatible; the patent-grade CN114015239A silicone compound and the PP shield show no surface degradation under standard household UV-C wavelengths and cycle times.
Note: The three ventilation holes should be checked after every sterilization cycle to confirm they remain clear and unclogged. A clogged ventilation hole reduces the EN 1400 ventilation provision performance of the shield.
Teat Head Selection and Age Safety
Round head: recommended for 0–6m use. If the infant shows consistent signs of attempting to chew or bite the nipple body (rather than suck), transition to the Strawberry or Spiral head which are engineered with greater material volume and surface detail for the 6m+ bite-force range.
Strawberry head: recommended for 6m+ infants entering the teething stage. The raised-dot surface is a molded silicone feature — it is not a coating or applied surface treatment and cannot separate from the nipple body during use.
Spiral head: recommended for 6m+ infants who have demonstrated stronger suction demand. The spiral grooves are molded features; inspect after each cleaning for any sign of tearing or cracking at the groove edges.
When to Replace
Replace the pacifier every 2–3 months under normal daily use, or immediately upon any of the following:
Visible cracks, tears, holes, or cuts in the nipple — particularly at the spiral groove edges (Spiral head) or around the dot-pattern base (Strawberry head)
Nipple feels sticky, unusually soft, or changes color
PP shield shows cracks, whitening stress marks, or dimensional deformation
Any of the three ventilation holes shows cracking or enlargement of the hole perimeter
Ring handle shows any crack at its base or junction with the shield disc
Nipple does not return to its original shape after full compression and release
Storage
Store in the supplied individual dust cover or a clean, dry container. Keep away from direct sunlight and heat sources. Do not store with items that may transfer scent or chemical residue. For the transparent shield variants, avoid prolonged UV exposure, which can cause slight yellowing of PP over time.
All care instructions are consistent with material specifications validated under EN 1400 and ASTM F963.
Step 1 — Inquiry
Submit requirements via https://www.mymitour.com/contact/ or email.
Include: target market (EU / US / other), head style(s) required (Round / Strawberry /
Spiral, or multi-style program), color combinations from standard 6 or custom Pantone
reference, logo method, packaging format (2pcs / 4pcs blister, retail box, OPP bag),
and certification requirements (EN 1400, CPC, ASTM F963, LFGB).
Response within 24 hours.
Step 2 — Sample (7 business days)
SP-1138 samples in requested teat style(s) and color combination(s) produced and
dispatched within 7 business days. Sample fee applies (refunded against first production
order above agreed volume). EN 1400 and CPC documentation scope confirmed at sample stage.
Step 3 — PO + 30% Deposit
Purchase order confirmed, 30% deposit received. Compliance documentation scope finalized.
Any custom Pantone color combination validated for EN 71-3 compliance before release.
Packaging dieline and FNSKU placement (for Amazon FBA) confirmed.
Step 4 — Production (25–35 days)
Full production run across specified teat style(s) and color combinations.
Inline QC at three checkpoints: incoming silicone compound verification (CN114015239A
spec), in-process (nipple molding + shield assembly + ventilation hole inspection),
pre-shipment (ventilation hole clearance, shield dimensional check, pull-force sample
test on ring handle, visual cosmetic inspection of twin-color match).
Step 5 — QC + Compliance Documents
Pre-shipment inspection report issued. Compliance package compiled:
EN 1400 test report (shield dimensions, pull force, ventilation, migration),
ASTM F963 report, CPC certificate, FDA material declaration,
BPA/BPS/phthalate-free statement, REACH/ROHS declaration, BSCI audit summary.
Step 6 — Balance Payment + Shipment
Balance payment received. EXW/FOB Shenzhen dispatch, or CIF by arrangement.
Standard master carton: 300 pcs / 500 × 350 × 350 mm / 4 kg — logistics-optimized.
Amazon FBA prep (FNSKU labeling, polybag with suffocation warning, carton labeling)
completed before dispatch.
Q1: What is the difference between the three teat styles, and which should I order first?
A: The three teat styles address three distinct developmental stages. The Round head is a smooth, classic round nipple designed for 0–6m infants — the standard starting point for most first-time buyers, as it serves the broadest initial age band and photographs as a clean, category-standard pacifier. The Strawberry head (6m+) has a raised-dot textured surface across the nipple body, designed for the teething period — the texture provides mechanical stimulation to the gum surface during sucking, which many parents find reduces teething-related fussiness. The Spiral head (6m+) features a ridged column nipple with spiral groove detailing, suited for infants who have developed stronger suction mechanics at 6 months and may be beginning to reject a low-resistance smooth nipple. Most buyers start with Round head or with all three simultaneously to build a full stage-progression product family. The compliance documentation for all three teat styles can be covered under a single EN 1400 test campaign, since they share the same PP shield platform and silicone material specification (CN114015239A).
Q2: Is it safe to use a PP plastic shield instead of a full-silicone shield?
A: Yes — polypropylene is a long-established food-contact-safe material used extensively in infant feeding products (bottles, sippy cups, breast pump components). PP used in the SP-1138 shield complies with FDA food-contact regulations, EU Regulation (EC) No. 10/2011 for plastic materials in contact with food, and the shield's material properties are included in the EN 1400 compliance test submission. PP offers a specific structural advantage over full-silicone shields: it maintains its circular geometry under repeated compressive jaw load, ensuring the shield-dimension compliance margins required by EN 1400 are maintained throughout the product's full recommended use life.
Q3: What temperature can the PP shield handle? Can I boil the whole pacifier?
A: Standard polypropylene (PP) has a melt temperature above 160°C and is rated for boiling water sterilization (100°C) without dimensional deformation. The SP-1138's PP shield can be boiled alongside the silicone nipple in the same cycle — 5 minutes in clean boiling water is the recommended cycle for both materials. The shield should be inspected after each boiling cycle: if any whitening, stress-cracking, or visible deformation is observed, the unit should be replaced. The silicone nipple, manufactured under Invention Patent CN114015239A, is independently validated for thermal stability up to 134°C steam sterilization. Both materials are compatible with electric steam, microwave steam, and UV-C sterilizer formats.
Q4: What do the 3 ventilation holes do, and why do they matter for EN 1400?
A: The three ventilation holes serve two purposes. First, they allow airflow across the contact area between the shield and the infant's perioral skin, reducing moisture accumulation from saliva — a hygiene benefit particularly relevant for infants with sensitive skin. Second, EN 1400 Clause 5.5 requires pacifier shields to incorporate ventilation openings of specified minimum dimensions and placement, designed to maintain air exchange in the oral cavity in the event the pacifier is inadvertently drawn fully inward. The SP-1138's three holes are dimensioned and positioned to satisfy the EN 1400 Clause 5.5 ventilation provision, as confirmed in the third-party test report. Buyers should include this EN 1400 ventilation compliance in their product safety documentation for EU market entry.
Q5: What does "twin-color combination" mean, and do the colors separate or bleed?
A: "Twin-color" refers to the contrasting color pairing of the PP shield and the silicone nipple — for example, a light pink shield paired with a light blue nipple. The two components are produced separately in their respective colors and assembled — there is no pigment mixed across the material boundary. The shield color is integral to the PP molding (color compounded into the PP before molding, not surface-painted), so it cannot chip, flake, or peel. The nipple silicone color is similarly compounded into the silicone before vulcanization — it is not a surface coat. All six standard twin-color combinations are validated for EN 71-3 heavy metal migration compliance from the colorants used in both materials. Custom Pantone combinations are validated for EN 71-3 compliance before production release as part of the standard OEM process.
Q6: Does the ring handle detach? How is it tested?
A: The ring handle is an integrally molded feature of the PP shield — the ring and the disc are a single, continuous molded component with no joint, adhesive, or weld interface. This means there is no failure mode associated with the ring separating from the shield under normal use. EN 1400 Part 2 specifies a pull-force test applied to protrusions and handles on pacifiers to confirm they cannot be detached under foreseeable use conditions. The SP-1138's integrally molded ring passes the EN 1400 pull-force test with margin, as confirmed in the third-party test report. The ring's internal diameter is sized to accept standard pacifier-clip attachment hardware for buyers who sell the pacifier paired with a clip or holder chain.
Q7: What are the retail packaging options and can I specify 2pcs vs 4pcs for different channels?
A: The SP-1138 supports both 2pcs per retail unit and 4pcs per retail unit configurations. For specialty baby retailers and boutiques, the 2pcs format is the standard; for mass-channel retailers (supermarkets, pharmacy chains, value clubs), the 4pcs format offers better per-unit shelf economics. Both formats are available in blister card, full-color retail box, and OPP bag with hangtag configurations. Custom box dimensions, window-cut options for nipple visibility, and FNSKU barcode placement for Amazon FBA are included in Mitour's standard packaging service. Buyers can specify different packaging formats for different retail channels within the same production order (e.g., 150 pcs in 2pcs blisters for boutique and 150 pcs in 4pcs retail boxes for pharmacy chain).
Q8: Is MOQ 300 pcs really one full master carton? How does this work logistically?
A: Yes — the standard master carton specification for the SP-1138 is exactly 300 pcs per carton (500 × 350 × 350 mm, 4 kg gross weight). This means the MOQ of 300 pcs is calibrated to equal one complete master carton — no partial-carton remnant, no mixed-product carton fill, no logistics complexity for a minimum order. A buyer can place a first order of 300 pcs, receive exactly one carton, and have a fully organized first shipment with no mixed product. For orders above 300 pcs, the quantity should be specified in multiples of 300 for clean carton optimization, though non-standard quantities can be accommodated with partial-fill cartons by arrangement.
Q9: How do the Strawberry head's raised dots hold up to extended use and cleaning?
A: The raised-dot pattern on the Strawberry head nipple is a molded silicone feature — part of the same continuous silicone body as the nipple, vulcanized from the CN114015239A compound. It is not an applied surface treatment, printed pattern, or secondary process addition. This means the dots cannot separate, delaminate, or wash off during boiling, steam sterilization, or UV-C sterilizer cycles. Under normal 6m+ infant use, the dot surface should show no visible degradation for the recommended 2–3 month use life. If any dot shows tearing, cracking, or distortion, the pacifier should be replaced. For buyers presenting the Strawberry head to EU retail buyers, the molded surface feature is included in the EN 1400 mechanical and physical properties test submission (bite force test applies to the full nipple body including surface features).
Q10: Can I order all three teat styles in the same production run at MOQ 300 pcs total?
A: The MOQ of 300 pcs applies to the total SP-1138 order, not per teat style. Whether a buyer orders 300 pcs of a single teat style or splits 300 pcs across Round, Strawberry, and Spiral variants (e.g., 100 pcs each), the MOQ is met and the production lead time applies uniformly. Note that a three-style split of 100 pcs each means each teat style is produced at 100 pcs — which may affect per-color minimum quantities within each teat style for twin-color options. Buyers planning a multi-style split order should confirm color allocation with Mitour's sales team during inquiry. For buyers uncertain about the optimal split, Mitour recommends starting with the Round head at full MOQ 300 pcs to establish baseline compliance documentation, then adding Strawberry and Spiral heads in subsequent orders. Submit your multi-style inquiry at /contact/.
Q11: What certifications are included, and are they reissuable under my brand name?
A: The SP-1138 is certified to EN 1400 (EU), ASTM F963 (US), CPC/CPSIA (US retail and Amazon), FDA, LFGB, EN 71 (including EN 71-3 for colorants), BSCI, SEDEX, ISO 9001:2015, and ROHS/REACH. Mitour holds master test reports from accredited third-party laboratories for all infant-specific standards. For private-label buyers, the EN 1400 test report and CPC certificate are reissuable under the buyer's brand name as part of the standard OEM compliance package — a requirement for EU market entry (CE Technical File) and Amazon pacifier listing approval respectively. The reissue process is included in the standard OEM service and does not require a separate test campaign unless the buyer makes material modifications to the product.
Q12: Can I add custom head text or a logo to the shield without affecting EN 1400 compliance?
A: Logo and text additions to the shield surface using Mitour's six standard methods (roller print, silk screen, laser engraving, UV full-color, heat transfer, water transfer) do not affect EN 1400 compliance, provided the additions do not alter the shield's dimensional properties (which they do not) or introduce new colorant migration risks (which are assessed as part of the EN 71-3 colorant validation process). Laser engraving is the preferred method for buyers concerned about any migration risk, as it is a subtractive process with zero ink or dye addition. UV full-color and heat transfer methods introduce printing inks that are separately validated for EN 71-3 compliance. Silk screen is the most commonly used method for standard pacifier shield branding. Your account manager will confirm the logo method selection and any associated EN 71-3 re-testing requirement during the sample stage.
Q13: What is the difference between the 2pcs "day + night" pack and a standard 2pcs pack?
A: The SP-1138's Round head is available in both a transparent khaki (day-use) and transparent bean green (night-use) twin-color version. These two variants are designed to create a "day-use + night-use" 2pcs retail bundle — a pack where both units share the transparent shield but are distinguished by their nipple color for easy daytime-versus-nighttime identification. This is a retail merchandising convention in the EU baby accessories market where transparent-shield variants of pacifiers are marketed as "clean/observable" (transparent shield allows nipple condition inspection without removal) and paired as a day-and-night pair for parental convenience. The 2pcs day+night pack is a standard retail configuration for the SP-1138 and is available as a pre-designed packaging option without requiring custom packaging development.
Q14: How does the SP-1138 differ from Mitour's Soother Pacifier (full-silicone shield)?
A: The key structural and positioning differences are: (1) Shield material: the Soother Pacifier uses a full-silicone shield throughout; the SP-1138 uses a PP shield for dimensional stability under jaw load. (2) Teat style options: the Soother Pacifier has a single classic round nipple; the SP-1138 offers three developmentally staged head styles. (3) Color architecture: the Soother Pacifier uses 8 single-material solid colors; the SP-1138 uses 6 twin-color bicolor combinations (shield + nipple contrast). (4) Weight: the Soother Pacifier is 18.5g; the SP-1138 is 8.4–9.4g (ultra-light range). (5) Handle: the Soother Pacifier has a pull-tab style handle integrated into the shield geometry; the SP-1138 has a dedicated ring loop optimized for pacifier clip attachment. Buyers who prioritize full-silicone construction and a single broad-age-band SKU should consider the Soother Pacifier; buyers who need a staged multi-head system with bicolor shelf impact and ultra-light construction should choose the SP-1138. Both products carry full EN 1400 and CPC certification.
Q15: Are Mitour's factory audits available for review before placing an order?
A: Yes. Mitour has completed and passed factory audits by Walmart (2019), Target (2019), and Disney (2022). Audit summaries are available under NDA for qualified buyers. In addition, BSCI and SEDEX social compliance documentation is available upon request. ISO 9001:2015 and ISO 14001 certificates are available for direct download from the certifications page. For buyers in the EU conducting their own supplier due diligence, Mitour can arrange a third-party factory audit through a buyer-nominated inspection agency at the buyer's cost. Background on Mitour's factory capabilities, including the 4,500 m² facility, 20+ production machines, and 30,000 pcs/day output capacity, is available at /about/.
Fields: Name · Company · Email · Country · Teat styles required (Round / Strawberry / Spiral / Multiple) · Color combination preference (standard 6 or custom Pantone) · Estimated quantity · Target market (EU / US / Other) · Certification requirements · Additional notes
