Customized One Way Valve Silicone Rubber Umbrella Check Valve for Medical Resuscitator Manufacturing

Overview

Our Customized One-Way Valve Silicone Rubber Umbrella Check Valve is a critical, precision-engineered component designed for reliable, fail-safe operation in medical resuscitators and respiratory devices. Crafted from biocompatible, medical-grade Liquid Silicone Rubber (LSR) via high-precision injection molding, this valve ensures unidirectional airflow, prevents backflow, and maintains sterile integrity under demanding clinical conditions. It is engineered for sensitive cracking pressure, consistent flow rates, and long-term durability through repeated sterilization cycles. Our factory provides full OEM service, from material selection and valve design to validation and cleanroom production, delivering custom solutions that meet the exacting specifications of life-supporting medical equipment.

Basic Information

Benefits of Our Products

• Medical-Grade Material Safety: Manufactured from certified, biocompatible LSR, ensuring patient safety, chemical inertness, and compliance with stringent medical device regulations.

• Precision Engineered Performance: The umbrella design is optimized for low, consistent cracking pressure and reliable sealing, critical for sensitive pressure control in manual resuscitators and ventilatory support circuits.

• Durability & Sterilization Resilience: Designed to withstand repeated high-temperature autoclaving and chemical sterilization without degradation of mechanical properties or sealing function, ensuring long device service life.

• Full Customization & Validation Support: We tailor every aspect—dimensions, skirt geometry, slit design, and material durometer—to your device’s specific pressure and flow requirements, supported by design verification and validation (V&V) protocols.

Quality Assurance

Our quality assurance for medical umbrella valves is anchored in our ISO 13485:2016 certified quality management system, specifically designed for medical devices. Each production batch utilizes fully traceable, lot-controlled medical-grade LSR. We perform 100% critical dimension inspection using automated vision systems, along with batch sampling for rigorous functional testing. This includes precise cracking/resealing pressure testing, flow rate verification, leak testing under negative and positive pressure, and accelerated lifecycle endurance testing (>100,000 cycles). Furthermore, we provide material certifications and can support biocompatibility testing (ISO 10993) and sterilization validation for the finished component, ensuring full compliance for your medical device assembly.

Why Partner with Us for Your Manufacturing Needs?

1. Dedicated Medical Device Expertise: Our specialized experience in manufacturing critical fluid path components for medical applications ensures an understanding of regulatory, performance, and reliability requirements.

2. End-to-End Regulated Manufacturing: We offer comprehensive OEM services within a controlled, ISO 13485 environment—from design input and risk management to cleanroom molding, inspection, and documented traceability.

3. Efficient & Compliant Project Execution: Our streamlined workflow, from prototyping to production, emphasizes clear documentation, design controls, and timely communication, ensuring projects meet both technical specs and regulatory pathways.

4. Commitment to Certified Quality & Safety: Our adherence to international medical device standards and stringent in-process controls guarantees that every valve is manufactured to the highest levels of quality, safety, and consistency required for patient care.

Factory Show

Our manufacturing facility includes a dedicated, Class 100,000 (ISO Class 8) cleanroom environment for the production of medical-grade silicone components. This area houses automated LSR injection molding machines with closed-loop process control to ensure batch-to-batch consistency. Our in-house toolroom, equipped with CNC machining centers and mirror-finish EDM, produces high-precision, validated molds. Within the controlled environment, post-molding processes like deflashing and cleaning are performed to particulate standards. Final inspection utilizes cleanroom-compatible testers for pressure, flow, and leak performance. This integrated, certified production ecosystem ensures the integrity, cleanliness, and reliability of every umbrella check valve destined for life-critical medical devices.