Overview
Our Silicone Umbrella/Mushroom One-Way Valve for Manual Resuscitators is a critical, precision-engineered component designed for reliable, fail-safe operation in emergency respiratory care. Manufactured from biocompatible, medical-grade Liquid Silicone Rubber (LSR) using cleanroom injection molding, it ensures a sterile, consistent seal to prevent cross-contamination and ensure unidirectional airflow. This valve is essential for patient safety and device efficacy.
Basic Information
| Attribute | Details |
|---|---|
| Material | USP Class VI, ISO 10993-5/10 Compliant LSR |
| Place of Origin | Xiamen, China |
| Brand Name | OEM |
| Product Type | Umbrella/Mushroom Check Valve |
| Size | Standard & Custom Sizes (to fit common resuscitator ports) |
| Color | Translucent, Medical White, or Color-Coded |
| Hardness (Shore A) | 40 – 60 (Optimized for rapid response & sealing) |
| Cracking Pressure | < 1 cm H₂O (Very low, to minimize breathing effort) |
| Sterilization | ETO, Gamma Radiation, Autoclave Compatible |
| Certifications | ISO 13485, FDA 21 CFR 177.2600, RoHS |
| Molding Process | Cleanroom LSR Injection Molding |
| OEM/ODM | Available |
| MOQ | Pilot and Production Batches Supported |
| Sample | Can Be Provided |
Benefits of Our Products
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Ensures Patient Safety & Airway Integrity: The one-way valve design is critical for preventing exhaled air or gastric contents from re-entering the patient circuit or device bag, protecting both patient and caregiver.
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Rapid, Low-Resistance Response: Engineered for minimal cracking pressure, ensuring the valve opens effortlessly during inhalation without impeding ventilation, which is vital during manual resuscitation.
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Reliable Sterility & Biocompatibility: Manufactured in a controlled cleanroom environment from certified materials, guaranteeing safety for single-use or resterilizable applications.
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Durable & Chemically Resistant: Withstands repeated compression and exposure to disinfectants, maintaining performance and integrity over the device’s service life.
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Designed for Seamless Integration: Precise dimensions ensure a secure, leak-proof fit within the resuscitator’s valve housing, enabling reliable assembly and function.
Quality Assurance
Our quality assurance system is governed by ISO 13485 for medical device manufacturing. We enforce strict material traceability with Certificates of Analysis (CoA). Every production batch undergoes 100% functional testing for cracking/reseal pressure and leak integrity using calibrated test equipment. Dimensional inspection is performed with optical measurement systems. We validate biocompatibility and performance through rigorous testing, including flow rate analysis and cycle life testing simulating emergency use scenarios, ensuring each valve meets the critical demands of life-support equipment.
Why Partner with Us for Your Manufacturing Needs?
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Specialization in Critical Medical Components: We possess focused expertise in designing and manufacturing life-critical silicone valves for respiratory and medical applications.
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Full Regulatory & Compliance Support: We operate under an ISO 13485 QMS and provide comprehensive documentation to support your device’s regulatory submission and audit requirements.
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Certified Cleanroom Production: Our dedicated cleanroom molding ensures the sterility and particulate control required for Class II medical devices like resuscitators.
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Commitment to Reliability & Precision: We understand the zero-failure tolerance of emergency medical equipment and engineer our valves and processes accordingly.
Factory Show
Our manufacturing facility features an ISO Class 8 cleanroom dedicated to medical LSR molding. The production cell includes automated injection molding machines with closed material systems. Our in-house tooling is crafted using high-precision CNC and EDM machining. Integrated within the cleanroom are automated vision inspection systems and custom functional testers that validate every valve’s performance in real-time. This controlled, vertically integrated environment ensures the production of reliable, safe, and consistent one-way valves for global medical device manufacturers.
