Overview
Our White Label Umbrella Check Valve for Medical Usage ensures precise one-way fluid control in devices like CPAP machines, ventilators, and infusion pumps. Made from medical-grade silicone, these valves feature a flexible, umbrella-shaped design for reliable backflow prevention and low cracking pressure. Designed for biocompatibility and durability, they meet the highest medical standards, making them ideal for life-critical applications. We offer full OEM services, including custom sizes, color matching, and logo integration to meet your regulatory and functional needs.
Basic Information
| Attribute | Details |
|---|---|
| Material | USP Class VI, ISO 10993-5/10 Compliant LSR |
| Place of Origin | Xiamen, China |
| Brand Name | OEM / White Label |
| Product Type | Medical Umbrella (Mushroom) Check Valve |
| Size & Profile | Fully Customizable |
| Color | Medical White, Translucent |
| Hardness (Shore A) | 30 – 50 (Customized for application) |
| Crack Pressure | 0.5 – 15 kPa (Engineered to specification) |
| Sterilization Methods | ETO, Gamma, Autoclave, E-Beam |
| Certifications | ISO 13485, FDA 21 CFR 177.2600, RoHS, REACH |
| Molding Process | Cleanroom LSR Injection Molding |
| OEM | Available |
| MOQ | Project-based, low-volume batches supported |
| Sample | Can be provided for evaluation |
Benefits of Our Products
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Guaranteed Biocompatibility & Safety: Manufactured from certified, medical-grade LSR with ultra-low extractables, ensuring safety for patient contact and critical fluid pathways.
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Reliable Contamination Prevention: The umbrella design provides a positive seal to prevent dangerous backflow, protecting system integrity in IV, respiratory, and diagnostic applications.
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Certified Cleanroom Production: Manufactured in an ISO Class 8 (or better) controlled environment, meeting stringent particulate and bioburden standards for medical devices.
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Validated Sterilization Performance: Engineered to maintain dimensional stability, sealing function, and material properties through validated sterilization cycles.
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Seamless Device Integration: Fully customizable for optimal performance and assembly, whether for press-fit, overmolding, or adhesive bonding within your device.
Quality Assurance
Our quality assurance is built upon our ISO 13485 certified quality management system, ensuring full traceability from raw material to finished valve. We enforce strict material qualification with Certificates of Analysis (CoA). Each production lot undergoes 100% automated optical inspection for defects and dimensional accuracy, alongside statistical functional testing for crack pressure, leak integrity, and flow performance. Comprehensive documentation, including Device History Records (DHR) and validation reports, supports your regulatory submissions and audit readiness.
Why Partner with Us for Your Manufacturing Needs?
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Proven Medical Device Supplier: We specialize in supplying critical, precision silicone components to the medical industry, with deep expertise in regulatory pathways and design controls.
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Comprehensive White Label & OEM Service: We function as your seamless manufacturing partner, offering complete solutions from collaborative design and prototyping to certified, scalable production under your brand.
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Scalable Cleanroom Manufacturing: Our dedicated cleanroom molding lines ensure product purity and are equipped to scale efficiently from R&D and pilot runs to high-volume commercial supply.
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Compliance-First Partnership: We prioritize your regulatory success, providing the essential documentation, material certifications, and technical files required for FDA, CE, and other global market approvals.
Factory Show
Our manufacturing facility features a dedicated ISO Class 8 cleanroom complex for medical production, equipped with automated LSR injection molding machines and closed material handling systems. Our precision toolroom, with CNC machining and mirror EDM capabilities, produces high-tolerance molds. Integrated within the cleanroom are automated optical inspection (AOI) stations and custom functional testers that validate each valve’s dimensions, crack pressure, and seal integrity. This vertically integrated, controlled environment under our ISO 13485 system ensures the consistent production of reliable, white-label medical check valves for global device manufacturers.
