Overview
Our Custom Food Grade LSR Injection Molding Baby Silicone Nipple Pacifiers are precision-engineered to deliver safety, comfort, and reliable performance for infant care products. Manufactured from premium food-grade liquid silicone rubber (LSR) compliant with FDA 21 CFR 177.2600 and EU 10/2011 standards, these nipple pacifiers are free of BPA, latex, and phthalates. Using high-precision LSR injection molding under cleanroom conditions, we ensure ultra-smooth surfaces, consistent wall thickness, and structural integrity that withstands repeated sterilization and daily use. Designed with infant oral development in mind, our nipples and pacifiers support orthodontic shapes, balanced airflow, and soft yet durable tactile properties. From prototyping to volume production, we offer full OEM customization—including size, flow rate, color, and packaging—to meet the needs of global baby care brands.
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Basic Information
| Attribute | Details | 
|---|---|
| Place of Origin | Xiamen, China | 
| Brand Name | OEM / Custom Branding | 
| Product Type | Baby Silicone Nipples, Pacifiers, Orthodontic Soothers | 
| Material | Food Grade LSR (FDA, LFGB, EU 10/2011 Compliant) | 
| Size Range | Nipple Height: 15–35 mm; Shield Diameter: 40–60 mm (Customizable) | 
| Hardness | Shore A 10–25 (Ultra-Soft to Soft, Customizable) | 
| Flow Rate (Nipples) | Slow, Medium, Fast, Variable Flow (Custom Hole Design) | 
| Temperature Resistance | -60 °C to +220 °C (Autoclavable) | 
| Certification | ISO 13485, FDA, LFGB, EN 1400, REACH, RoHS | 
| MOQ | 5,000 Pieces (Flexible for Established Projects) | 
| Sample Lead Time | 7–10 Business Days | 
| Production Lead Time | 25–35 Business Days | 
| Packaging | Sterile Pouches, Blister Packs, Retail Boxes | 
Key Benefits
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Ultra-Safe & Non-Toxic – Made from 100% medical-origin food-grade LSR, complying with international safety standards for infant oral contact.
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Designed for Oral Development – Orthodontic shapes, symmetrical designs, and vented shields support healthy palate and tooth development.
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Easy Clean & Sterilizable – Smooth, seamless surfaces prevent bacterial buildup; withstands repeated steam, boiling, or UV sterilization.
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Precision Flow Control – Laser-drilled or molded hole designs ensure consistent flow rates for milk, formula, or liquid nutrition.
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Durability & Tear-Resistance – Reinforced neck and shield design resists biting and stretching, extending product life.
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Custom Aesthetics & Ergonomics – Available in translucent or skin-toned shades, with optional glow-in-the-dark shields or printed patterns.
 
Product Types & Configurations
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Orthodontic Pacifiers – Symmetrical nipple shape with air vents for balanced pressure
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Single- or Multi-Hole Nipples – Round, cross-cut, or variable flow designs
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All-Silicone One-Piece Pacifiers – Integrated shield and nipple for safety and simplicity
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Vented Anti-Colic Nipples – Internal valve systems to reduce air ingestion
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Glow-in-the-Dark Shields – Parent-friendly visibility in low-light conditions
 
Manufacturing Process & Quality Assurance
We employ high-precision LSR injection molding in an ISO Class 7 cleanroom environment to ensure product purity and dimensional repeatability. Each batch undergoes:
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Material Certification – FTIR validation and batch traceability of food-grade LSR
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Dimensional Inspection – CMM and optical comparators verify nipple hole size, wall thickness, and shield geometry
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Physical Testing – Tear strength, tensile tests, and cyclic compression to simulate long-term use
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Flow & Leak Testing – Automated flow rate verification and leak testing under simulated feeding conditions
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Safety & Compliance Testing – Migration testing, heavy metal screening, and compliance with EN 1400 (pacifier safety)
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Sterilization Validation – Steam autoclave and boiling water cycle testing
 
Factory Capabilities
Our baby care product manufacturing facility operates state-of-the-art, high-precision LSR injection molding systems equipped with 8 to 32-cavity cold runner molds, ensuring high output and material efficiency. We utilize mirror EDM and micro-EDM technologies to achieve SPI A1/A2-class surface finishes on mold details, delivering ultra-smooth, safe surfaces free of parting lines or micro-defects. All molding, assembly, and packaging processes are conducted within an ISO Class 7 cleanroom environment to maintain stringent hygiene standards. Our integrated capabilities include in-house tooling design, CNC machining, and laser drilling for precision orifice formation, supported by automated vision inspection systems that perform real-time defect detection and dimensional verification. Additionally, we offer custom printing, retail-ready packaging, and sterilization services—providing a complete, quality-assured manufacturing solution for sensitive baby care products.
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