Medical Grade Silicone Respiratory Mask — Wacker ELASTOSIL® R 401/30

Product Description

Medical Grade Silicone Anesthesia & Respiratory Mask Engineered for critical care and surgical environments, our medical-grade silicone respiratory masks are manufactured from Wacker ELASTOSIL® R 401/30 high-consistency silicone rubber (30 Shore A). This material is specifically formulated for repeated patient contact and passes FDA §177.2600, USP Class VI, ISO 10993, and BfR XV biocompatibility standards — making it suitable for anesthesia delivery, ICU ventilation, emergency resuscitation, and oxygen therapy. Material & Compliance The Wacker ELASTOSIL® R 401/30 compound delivers: • Hardness: 30 Shore A (optimal balance of softness and structural stability for facial sealing) • Tensile strength: ≥10 N/mm² | Elongation at break: ≥720% • Operating temperature range: -55°C to +210°C • Post-cured at 200°C for 4 hours to eliminate volatile residues, ensuring compliance with FDA extractable limits Manufacturing Process Produced via compression molding with peroxide curing (0.7% C1 crosslinker or 1.5% E-type), followed by mandatory secondary post-curing. Flash-free parting lines and burr-free edges are achieved through precision tooling and controlled compression parameters. Fluoropolymer-based mold release is used — no silicone oil residue that could compromise seal integrity or downstream bonding. Key Features • Airtight Seal: Ergonomic contour adapts to varied facial geometries, minimizing gas leakage during positive-pressure ventilation • Patient Comfort: 30 Shore A softness reduces pressure marks during prolonged use (2–8 hour procedures) • Sterilization Compatible: Withstands repeated autoclave (121°C / 134°C), ETO, and Gamma irradiation cycles without material degradation • Optical Clarity: Translucent natural finish allows clinical staff to visually inspect for condensation, secretions, or contaminants inside the mask • Reusable: Designed for multi-cycle use in hospital environments (subject to institutional sterilization protocols) Applications Anesthesia machines • ICU ventilators • Emergency resuscitation bags • Oxygen therapy circuits • CPAP/BiPAP interfaces • Neonatal respiratory support Customization & OEM Service We provide full OEM/ODM support for medical silicone respiratory products: • Custom hardness (20–60 Shore A), color matching, and branding • Integrated mold design and tooling development • Optional overmolding with rigid plastic frames (PC/ABS) • Assembly, packaging, and sterilization-ready delivery All parts are produced under ISO 9001:2015 and ISO 13485:2016 certified quality systems, with FAIR, CMM inspection, and full material traceability documentation available on request.

Request Quote Customize ← Back to Products