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​Medical Silicone One-Way Check Valve | FDA/ISO13485 Certified | IP68 Waterproof | Customizable | High-Precision | Suitable for Respirators, Anesthesia Machines

​Medical Silicone One-Way Check Valve | FDA/ISO13485 Certified | IP68 Waterproof | Customizable | High-Precision | Suitable for Respirators, Anesthesia Machines

​Medical Silicone One-Way Check Valve | FDA/ISO13485 Certified | IP68 Waterproof | Customizable | High-Precision | Suitable for Respirators, Anesthesia Machines
​Medical Silicone One-Way Check Valve | FDA/ISO13485 Certified | IP68 Waterproof | Customizable | High-Precision | Suitable for Respirators, Anesthesia Machines​Medical Silicone One-Way Check Valve | FDA/ISO13485 Certified | IP68 Waterproof | Customizable | High-Precision | Suitable for Respirators, Anesthesia Machines
CategoríaMedical Grade Silicone Overmolding
MarcaSiliconePlus | Silicone OverMolding Manufacturing
CertificationsFDA, ISO13485, CE
Temperature Range-40°C to +200°C-40°C 至 +200°C
Tiempo de Actualización2025/4/29
Información Detallada
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 至 +200°C
Compatibility
Compatible with various respirators, anesthesia machines, CPAP devices
Precision
±0.1mm±0.1
medical grade silicone face mask​
medical grade silicone face mask​
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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