Customized Medical Grade Silicone Umbrella Valve for CPAP Respirator Mask Usage Supplier

Overview

Our Customized Medical Grade Silicone Umbrella Valve is a precision-engineered critical component designed for CPAP (Continuous Positive Airway Pressure) respirator masks, ensuring patient safety, comfort, and therapeutic efficacy. Crafted from biocompatible, hypoallergenic Liquid Silicone Rubber (LSR) using high-precision cleanroom injection molding, this valve facilitates precise, quiet, and reliable venting of exhaled gases to prevent CO₂ rebreathing. It is engineered for exceptional durability, consistent flow performance, and seamless integration with mask housings. We provide complete OEM services—from collaborative design and material validation to sterile-ready production—delivering a fully documented, ISO 13485-compliant solution tailored to the exacting requirements of sleep therapy and respiratory care devices.

Basic Information

Benefits of Our Products

• Precision Therapeutic Venting: Engineered for consistent, diffusion-style flow to effectively eliminate exhaled CO₂ while maintaining prescribed CPAP pressure, crucial for patient safety and treatment comfort.

• Superior Patient Comfort & Safety: Manufactured from skin-safe, hypoallergenic LSR, ensuring biocompatibility for prolonged nightly use and minimizing the risk of irritation.

• Reliable, Leak-Free Performance: The umbrella design provides a positive seal against unintended leaks, ensuring pressure stability and reducing audible noise for both the user and bed partner.

• Durable & Easy to Maintain: Resists degradation from moisture, facial oils, and repeated cleaning with common CPAP mask wipes or mild soap, ensuring long service life.

• Design-Integrated Solution: Fully customizable for optimal fit and function within your mask assembly, whether for direct overmolding, press-fit, or adhesive attachment.

Quality Assurance

Our quality assurance is integral to our ISO 13485 certified quality management system, specifically tailored for medical device manufacturing. We enforce strict material traceability with full Certificates of Analysis (CoA). Each production batch undergoes 100% automated optical inspection (AOI) for critical dimensions and visual defects. Functional performance is rigorously validated through statistical sampling using calibrated flow testers and pressure decay leak testers to ensure precise flow-resistance curves and seal integrity. Our processes include cleanroom particulate monitoring, and we provide comprehensive validation documentation, including material biocompatibility reports, performance data, and full Device History Records (DHR) for regulatory compliance and lot traceability.

Why Partner with Us for Your Manufacturing Needs?

1. Specialization in Medical Respiratory Components: We possess dedicated expertise in designing and manufacturing silicone valves for respiratory applications, with a deep understanding of the critical balance between therapeutic performance, comfort, and reliability.

2. End-to-End Medical Device Partnership: We offer a complete, regulated OEM service from initial concept and DFM through to validation, scalable cleanroom production, and supply of sterile-ready components.

3. Certified Cleanroom Manufacturing Environment: Our dedicated ISO Class 8 cleanroom LSR molding lines guarantee the particulate control and microbiological standards essential for Class I/II medical devices like respiratory masks.

4. Commitment to Compliance & Documentation: We prioritize your regulatory pathway, providing the extensive design history files (DHF), verification/validation reports, and quality records required for FDA, CE, and other global market approvals.

Factory Show

Our manufacturing center features a dedicated medical-grade cleanroom (ISO Class 8) complex equipped with automated LSR injection molding machines and closed-material handling systems to ensure contamination-free production of CPAP valves. The supporting toolroom utilizes high-precision 5-axis CNC machining and mirror EDM to create molds that achieve the exacting tolerances and surface finishes required for consistent valve performance. Within the cleanroom, integrated quality stations feature laser measurement systems and custom-built functional testers that simulate breathing cycles to validate flow and leakage performance. This vertically integrated, controlled environment under our ISO 13485 system ensures the production of reliable, high-quality silicone umbrella valves that meet the critical demands of global respiratory care markets.