Overview
Our Custom One-Way Check Umbrella Valves for Medical Use are medical-grade silicone check valves engineered for reliable, low-dead-volume one-way flow in critical care devices (BVMs, ventilators, anesthesia circuits, infusion systems). Molded from biocompatible LSR/VMQ in contamination-controlled environments, they deliver ultra-low cracking pressure, repeatable reseal behavior, sterilization compatibility and full lot traceability for regulated medical programs.
Basic Information
| Attribute | Details |
|---|---|
| Material | Medical-grade LSR or VMQ silicone (FDA & ISO 10993 compatible compounds available) |
| Place of Origin | Xiamen, China |
| Brand Name | OEM / White Label |
| Size | Custom — typical ID 2–30 mm; umbrella diameter, stem length per drawing |
| Color | Translucent or Pantone color matched |
| Manufacturing | LSR injection molding (metered two-component) or precision compression molding |
| Tooling | 5-axis CNC, sinker & wire EDM, precision grinding, mirror polishing for sealing seats |
| Cleanroom | ISO Class 7 / Class 8 production & assembly options |
| Hardness (Shore A) | 10–60 (tuned to cracking pressure and media) |
| Cracking / Opening Pressure | Tunable ≈ 0.1 mbar to >500 mbar (engineered & validated per spec) |
| Flow Profile | Forward flow characterized to clinical flow rates; custom flow curves available |
| Operating Temp. | –60 °C to +200 °C (compound dependent; sterilization dependent) |
| Sterilization Compatibility | EtO, Gamma, Autoclave (121 °C) — sterilization validation available |
| Cycle Life | Typically >100k actuations; higher validated lifetimes available |
| Packaging | Sterile Tyvek/foil pouches, sealed trays, bulk sterile trays, or custom sterile packaging |
| Traceability | Lot/serial coding, material certificates, retained QA records |
| Regulatory Support | ISO 9001; ISO 13485 workflows available; ISO 10993 biocompatibility support |
| MOQ / Samples | Flexible — rapid prototype samples and small pilot lots supported |
Key Benefits
- Ultra-low, repeatable cracking pressure for low-effort manual ventilation and accurate dosing.
- Minimal dead volume from optimized umbrella geometry to preserve tidal accuracy and reduce contamination risk.
- Fast elastic recovery & low hysteresis for consistent reseal and cycle-to-cycle performance.
- Sterilization-ready compounds validated for EtO/Gamma/steam as required.
- Design flexibility — flange, snap-rib, overmold mounting options and integrated secondary seals.
- Hygienic production — closed metering LSR, robotic handling and cleanroom assembly lower contamination risk.
Quality Assurance
Manufacture follows ISO 9001 processes, with ISO 13485 workflows available for regulated device programs. Incoming raw materials are lot-verified and retained. Tools and processes are validated using capability studies before production. Inspection and test regimes include 100% visual/AOI checks, dimensional sampling with ZEISS CMM/optical profilers, durometer hardness checks, tensile/elongation spot tests and automated functional testing: cracking-pressure mapping, forward-flow characterization, leak/back-pressure tests, burst testing and cycle-life endurance. Sterilization validation, biocompatibility (ISO 10993) and extractables testing can be executed per program. Full batch documentation and traceability are provided with shipments.
Why Partner With Us?
- Medical elastomer expertise — proven track record supplying respiratory, infusion and critical-care components.
- End-to-end OEM capability — DFM, in-house tooling, cleanroom molding, post-cure conditioning, validation and sterile packing.
- Regulatory & validation support — assistance with ISO 10993 planning, sterilization protocols and submission documentation.
- Performance tuning — geometry + compound optimization to meet precise cracking pressure, flow and reseal targets.
- Flexible volumes — fast prototyping, pilot runs and scalable high-volume automated production with SPC control.
Factory Overview:
Our medical elastomer campus pairs precision toolmaking (5-axis CNC, sinker & wire EDM, precision grinding and mirror polishing) with automated LSR injection cells featuring closed-loop metering, hot-runner tooling and robotic extraction. Post-process includes controlled thermal post-cure ovens, ultrasonic/laser trimming and cleanroom assembly lines. Inspection assets include ZEISS CMM, high-resolution AOI, durometers, universal test frames and dedicated cracking-pressure / flow rigs capable of simulating clinical conditions. Sterile packaging, serialization and retained QA records ensure components are delivered sterile, traceable and ready for clinical integration.
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