Overview
OEM Medical Grade Membrane Silicone Rubber Diaphragm Valves are precision-molded components designed for accurate fluid and pressure control in medical devices. Made from biocompatible, medical-grade silicone, these diaphragms offer excellent elasticity, fatigue resistance, and chemical stability. Manufactured using high-precision LSR injection and compression molding, they ensure consistent sealing performance and long service life. We provide full OEM and one-stop services, including custom geometry, thickness, hardness, and validation support to meet stringent medical regulatory requirements.
Basic Information
| Attribute | Details |
|---|---|
| Place of Origin | Xiamen, China |
| Brand Name | OEM / White Label |
| Product Type | Silicone Rubber Diaphragm Valve |
| Material | Medical-Grade Silicone / LSR |
| Structure | Flat, Convoluted, Reinforced (Custom) |
| Color | Transparent or Customized |
| Hardness | 20–70 Shore A (Optional) |
| Thickness | Custom per Design |
| Size | Fully Customizable |
| Sample | Available |
| Certifications | ISO 13485, ISO 9001, FDA, LFGB, RoHS |
| Applications | Ventilators, infusion pumps, analyzers, fluid control systems |
Benefits of Our Silicone Diaphragm Valves
- Medical-grade, biocompatible silicone compliant with FDA standards
- Excellent flexibility and fatigue resistance for long cycle life
- Precise pressure response and reliable sealing performance
- High chemical, thermal, and hydrolysis resistance
- Custom molding for thickness, contour, and actuation sensitivity
- Suitable for critical, life-support medical applications
Quality Assurance
Our medical diaphragm valves are manufactured under a strict quality management system integrating ISO 13485 and ISO 9001 standards. We utilize FDA-approved medical-grade silicone with full material traceability and third-party compliance verification. High-precision LSR injection molding and silicone compression molding ensure uniform thickness, controlled elasticity, and repeatable diaphragm response. Each production lot undergoes comprehensive inspections, including dimensional verification, pressure-cycle testing, leak testing, tensile and elongation analysis, and aging validation. Compliance with FDA, LFGB, and REACH requirements ensures safe, reliable performance in demanding medical environments.
Factory Show
Our advanced manufacturing facility features precision CNC machining centers, mirror-finish EDM, conventional EDM, and slow-speed wire cutting systems for high-accuracy mold fabrication. Production is supported by 15 silicone compression molding machines and 2 high-precision LSR injection molding units, optimized for medical-grade clean production. Quality control is reinforced with 3D optical projectors, diaphragm sealing testers, Shore hardness testers, and elasticity measurement instruments operated by trained QC engineers. Automated drying, trimming, and inspection systems further enhance consistency and efficiency. All processes operate under ISO 9001 and IATF 16949 frameworks, ensuring stable, scalable OEM manufacturing for medical silicone components.
