Overview
Our Custom Medical Grade One-Way Silicone Rubber Umbrella (Mushroom) Check Valve is a precision-engineered fluid management component designed for reliability and safety in critical medical and diagnostic applications. Manufactured from certified biocompatible Liquid Silicone Rubber (LSR) in a certified cleanroom environment, this valve ensures a sterile, leak-proof seal to prevent backflow and contamination in devices such as respiratory equipment, IV sets, diagnostic cartridges, and wearable drug delivery systems. Utilizing high-precision LSR injection molding, we guarantee exceptional consistency and performance. Our full OEM service provides complete customization—from material validation and design for manufacturability (DFM) to sterile packaging—ensuring compliance with stringent medical device regulations and your specific application requirements.
Basic Information
| Attribute | Details |
|---|---|
| Material | USP Class VI, ISO 10993-5/10 Compliant LSR |
| Place of Origin | Xiamen, China |
| Brand Name | OEM |
| Product Type | Medical Umbrella / Mushroom Check Valve |
| Size & Dimensions | Fully Customizable |
| Color | Medical White, Translucent, or Custom |
| Hardness (Shore A) | 30 – 50 (Customizable for specific crack/open pressure) |
| Sterilization Compatibility | Autoclave, Gamma, ETO, E-Beam |
| Certifications | ISO 13485, FDA 21 CFR 177.2600, ROHS, REACH |
| Molding Process | Cleanroom LSR Injection Molding |
| OEM | Available |
| MOQ | Pilot and Production Volumes Supported |
| Sample | Can be provided (Non-Sterile or Sterile) |
Benefits of Our Products
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Guaranteed Biocompatibility & Safety: Manufactured from certified medical-grade LSR with low leachables and extractables, ensuring safety for patient contact and fluid pathways.
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Reliable Leak-Proof & Unidirectional Flow: The umbrella/mushroom design provides a positive seal against backpressure, critical for preventing cross-contamination and ensuring precise fluid direction in medical circuits.
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Precision Cleanroom Molding: Our controlled ISO Class 8 (or better) cleanroom LSR molding process ensures ultra-clean, flash-free, and dimensionally consistent parts vital for medical device assembly and function.
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Validated Sterilization Performance: Valves are designed and tested to maintain integrity and performance over repeated cycles of industry-standard sterilization methods.
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Application-Specific Customization: We engineer all parameters—including stem design, skirt profile, slit geometry, and opening pressure—to meet precise flow rate, pressure drop, and actuation force requirements for your device.
Quality Assurance
Our quality assurance system for medical-grade valves is governed by our ISO 13485 certification, ensuring traceability and control for medical device manufacturing. We employ full material lot traceability and Certificates of Analysis (CoA). Each production batch undergoes rigorous inspection: dimensional verification via vision systems and CMM, 100% functional testing for crack pressure and seal integrity, and sampled testing for critical attributes like extractables and leachables. Our dedicated cleanroom processes are routinely monitored for particulates and bioburden, and we provide comprehensive documentation packages to support your device regulatory submissions.
Why Partner with Us for Your Manufacturing Needs?
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Medical Device Manufacturing Expertise: We possess specialized experience in designing and producing silicone components for regulated medical markets, understanding the critical need for documentation, validation, and traceability.
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End-to-End Regulated OEM Service: We offer complete support from biocompatible material selection and design for manufacturability (DFM) to validation prototyping, sterile packaging, and full ISO 13485 compliant production.
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Dedicated Cleanroom Production & Scalability: Our dedicated cleanroom LSR injection molding lines ensure product purity and are scalable from low-volume pilot runs for R&D to high-volume commercial manufacturing.
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Commitment to Certified Quality & Compliance: Our quality management system is designed for medical devices, providing the rigorous process controls, documentation, and material certifications required by global regulatory bodies.
Factory Show
Our manufacturing facility features a dedicated, certified ISO Class 8 cleanroom environment for the production of medical silicone components. This space houses automated LSR injection molding machines with integrated cleanroom-grade material handling systems. Our in-house tooling center, with CNC machining and mirror EDM capabilities, produces high-precision molds. Within the cleanroom, post-molding processes include dedicated inspection stations with automated optical inspection (AOI) and functional testers. We also offer secondary services such as ultrasonic cleaning, automated packaging, and contract sterilization coordination, providing a vertically integrated and controlled supply chain for your critical medical valve components.