High-Precision Silicone Mold Production with CNC & EDM – Fast, and Medical-Grade Quality Assurance
group nameMedical Grade Silicone Overmolding
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Min Order1 piece
brand nameSiliconePlus | Silicone OverMolding Manufacturing
model41-lyasilicone20240428
payment methodT/T, L/C, MoneyGram, PayPal, Westem Union, Cash, Escrow
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update timeMon, 06 Apr 2026 22:15:31 GMT
Paramtents
Certifications FDA, ISO13485, CE
Temperature Range -40°C to +200°C-40°C to +200°C
Medical-Grade Silicone Medical-Grade SiliconeISO 13485 Certified
Packging & Delivery
Min Order1 piece
Briefing
medical grade silicone face mask, FDA/ISO13485 certified, IP68 waterproof, customizable for respirators & CPAP devices.
Detailed
Leveraging our in-house silicone mold technology and an annual production capacity of 500 molds, we utilize high-precision CNC machining and EDM spark erosion to achieve rapid delivery and stringent quality standards, meeting the medical industry's requirements for product accuracy and delivery timelines.
Product Specifications
Parameter Category | Example Specification |
| Model | OEM-Siliconeplus |
Dimensions | Customized according to drawings |
| Material | Medical-Grade Liquid Silicone Rubber |
| Power | No power required |
| Voltage | No voltage required |
Certifications | FDA, ISO13485, CE |
MOQ | 1,000 units |
Lead Time | Custom: 3-7 days; Mass Production: 15-30 days |
Temperature Range | -40°C to +200°C-40°C to +200°C |
Compatibility | Compatible with various respirators, anesthesia machines, CPAP devices |
Precision | ±0.1mm±0.1 |
Siliconeplus Advantages:
✅ 23+ Years of Silicone Expertise
With over two decades of experience in custom silicone manufacturing, we understand the unique needs of the medical industry.
✅ ISO & FDA Certified Production
We comply with global medical standards for material safety, product quality, and traceability.
✅ Customized One-Stop Service
From in-house mold development to rapid prototyping and mass production, Siliconeplus supports full customization to match your specifications.
✅ High-Transparency Silicone
The balloon features glass-like clarity to ensure accurate visual monitoring during procedures.
✅ Superior Material Properties
High temperature resistance, chemical stability, excellent elasticity, and long-term biocompatibility.
FAQ
What materials are used in your medical grade silicone face mask?
We use FDA-approved and ISO13485-certified medical-grade silicone, ensuring biocompatibility, flexibility, and long-term safety.
Are your silicone valves suitable for ventilators and CPAP machines?
Yes, our one-way silicone valves are specially designed for ventilators, CPAP, and other respiratory devices, with high sealing precision and stability.
What certifications do your products have?
Our products are certified by ISO13485 for medical device quality management and FDA food-grade standards; materials also comply with ROHS and REACH.
How fast can you deliver samples and bulk orders?
Samples are typically delivered within 3–7 days; bulk production delivery time is around 15–20 working days after order confirmation.
How do you ensure quality and consistency in production?
We have a complete ISO13485 quality management system, advanced precision molding equipment, and perform 100% functional testing before shipment.
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- Yantian (shenzhen,guangdong, china), Shekou (shenzhen,guangdong, china)
- Delivery clauses under the trade mode
- FOB
- Acceptable payment methods
- T/T, L/C, MoneyGram, PayPal, Westem Union, Cash, Escrow