Custom Medical Grade One Way Silicone Rubber Umbrella Mushroom Check Valve Injection Molding

Overview

Our Custom Medical Grade One-Way Silicone Rubber Umbrella Mushroom Check Valve is a precision-engineered fluid management component designed for reliability and sterility in critical medical and life science applications. Manufactured in a certified cleanroom environment using biocompatible Liquid Silicone Rubber (LSR) and high-precision injection molding, this valve ensures a fail-safe, leak-proof seal to prevent backflow and contamination. It is ideally suited for integration into diagnostic devices, IV sets, respiratory circuits, and drug delivery systems. We offer comprehensive OEM services—from design validation and material selection to sterile packaging—providing a fully documented and traceable solution that meets stringent ISO 13485 and global regulatory requirements.

Basic Information

Benefits of Our Products

• Guaranteed Biocompatibility & Safety: Manufactured from certified, high-purity medical-grade LSR with minimal extractables and leachables, ensuring safe contact with sensitive fluids and patient pathways.

• Reliable Unidirectional Flow Control: The umbrella/mushroom design provides a consistent, low-dead-volume seal, critical for preventing backflow contamination and ensuring precise fluid direction in medical circuits.

• Precision Cleanroom Manufacturing: Produced in a controlled ISO Class 8 (or better) cleanroom, guaranteeing the particulate control and microbiological standards required for invasive and critical-care medical devices.

• Validated Sterilization & Chemical Resistance: Engineered to maintain structural integrity, elasticity, and performance through repeated cycles of standard medical sterilization and exposure to aggressive chemicals.

• Full Customization & Regulatory Support: We collaborate to customize all functional parameters—including flow characteristics, connection interfaces, and pressure ratings—while providing the comprehensive documentation needed for regulatory submissions.

Quality Assurance

Our quality assurance is governed by our ISO 13485 certified quality management system, ensuring full traceability and control for medical device manufacturing. We enforce rigorous material qualification with Certificates of Analysis (CoA) and implement strict batch traceability. Each production lot undergoes 100% automated optical inspection (AOI) for critical dimensions and defects, alongside statistical functional testing for crack pressure, reseal integrity, and leak performance. Our processes include continuous cleanroom environmental monitoring, and we provide extensive validation support, including sterilization validation data and full Device History Records (DHR) to ensure compliance and product safety.

Why Partner with Us for Your Manufacturing Needs?

1. Specialization in Medical Silicone Components: We possess dedicated expertise in designing and manufacturing high-tolerance silicone parts for regulated medical markets, with a deep understanding of design controls and regulatory pathways.

2. End-to-End Regulated OEM Solution: We provide a seamless, single-source service from concept and DFM analysis through validation, scalable production, and sterile packaging, all within a certified QMS framework.

3. Scalable Cleanroom Production Capacity: Our dedicated cleanroom LSR injection molding lines ensure product purity and are capable of scaling efficiently from R&D prototyping to high-volume commercial supply.

4. Commitment to Compliance & Documentation: We prioritize regulatory compliance, providing the extensive documentation, material certifications, and validation support necessary for your successful regulatory approval and audit readiness.

Factory Show

Our advanced manufacturing facility features a dedicated, certified ISO Class 8 cleanroom complex equipped with automated LSR injection molding machines and closed-loop material handling systems to ensure contamination-free production. The supporting toolroom utilizes high-precision CNC machining centers and mirror EDM technology to craft molds that meet exacting medical tolerances. Within the cleanroom, integrated quality stations feature laser vision measurement systems for inspection and automated testers for functional validation. This vertically integrated, controlled environment, managed under our ISO 13485 system, ensures the consistent production of medical-grade valves with the reliability, traceability, and quality required for global healthcare applications.