Overview
Our Customization Soft Medical-Grade One-Way Check Silicone Umbrella Gasket Valves are precision-engineered sealing components for medical and life-science applications where reliable one-way flow, biocompatibility, and sterilization compatibility are mandatory. Molded from medical-grade LSR or platinum-cured silicone, these umbrella-style gaskets deliver low opening pressure, fast reseal, and long cycle life—ideal for infusion sets, respiratory devices, drainage systems, sampling ports, and single-use assemblies. We provide full OEM services: DFM, rapid prototyping, ISO-13485 tooling, validation runs, and scale production with sterile packaging options.
Basic Information
| Attribute | Details |
|---|---|
| Place of Origin | Xiamen, China |
| Brand Name | OEM / Private Label |
| Material | Medical-grade LSR / Platinum-cured silicone (USP/ISO biocompatible grades) |
| Valve Type | Umbrella (mushroom) gasket one-way check valve |
| Typical Size | 3 mm – 20 mm (OD) — custom sizes available |
| Cross-Section / Lip | Thin flexible lip design for ultra-low opening pressure |
| Hardness | Shore A 20–70 (customizable) |
| Tolerance | ±0.01 mm (custom tighter tolerances available on request) |
| Operating Temp. | -40 °C to +200 °C (autoclave stable ranges available) |
| Sterilization | Compatible: Autoclave (steam), EtO, Gamma (per material selection) |
| Molding Process | LSR injection molding / silicone compression molding; secondary micro-die cutting for slit features |
| Surface Finish | Smooth, medical polished (< Ra as specified) |
| Certifications | ISO 13485, ISO 9001, FDA (material declarations), RoHS; full 10993 biocompatibility available |
| MOQ | Flexible — small pilot runs accepted |
| Samples | Prototype samples: 7–14 days |
| Lead Time | Production: 20–35 days (tooling dependent) |
| Packaging | Tray, bulk, or sterile sealed pouch; custom labeling available |
Key Benefits
- Medical-Grade Safety: USP/ISO biocompatible silicone options and process controls to meet medical device requirements.
- Reliable One-Way Performance: Umbrella gasket geometry offers very low cracking pressure and rapid reseal to prevent backflow and contamination.
- Sterilization-Ready: Materials and designs tolerate common sterilization methods (autoclave, EtO, gamma) for reusable or pre-sterilized single-use products.
- Fully Customizable: Size, lip thickness, hardness, and surface finish tailored to fluid type, pressure regime, and device integration.
Quality Assurance
All valves are produced under an ISO 13485 medical-quality management system with full material traceability. Every production lot undergoes incoming raw-material verification, dimensional inspection using CMM/3D optical, functional flow & leak testing, seal-integrity and peel/adhesion tests (for overmolded interfaces), and sterilization validation per client protocol. Biocompatibility testing (ISO 10993 series), extractables & leachables support, and full QA documentation packages (IQ/OQ/PQ or PV) are available on request.
Why Partner With Us?
- Medical-Grade Expertise: ISO 13485 certified processes and decades of silicone LSR experience focused on regulated markets.
- End-to-End Service: Tooling, prototyping, validation, sterile packaging and logistics—single supplier for speed and traceability.
- Flexible Volume Support: From engineering samples and pilot builds to high-volume contract manufacturing.
- Regulatory Support: Material declarations, biocompatibility test coordination, and batch traceability to simplify client regulatory submissions.
Factory Show
Our facility integrates high-precision mold making (CNC 5-axis, Mirror EDM, slow-speed wire cutting), medical LSR injection molding machines in Class 7/ISO-controlled environments, and dedicated cleanroom assembly lines. Inspection and test equipment include ZEISS-class CMMs, 3D optical projectors, calibrated flow benches, sealed-port leak testers, durometers and tensile rigs. We run validated sterilization cycles and maintain full paperless traceability across production—ensuring consistent quality for every medical component we deliver.
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