Respirator & Mask Components
Face seals, valves and cushion components for respiratory masks — skin-safe and fatigue resistant.
Application Overview
CPAP and anesthesia mask cushions, headgear connectors and exhalation valve membranes take thousands of compression cycles against skin. We mold skin-contact LSR at low durometer with high tear strength, tuned for long-term comfort and repeatable valve function. Skin-contact grades are verified free of irritant extractables and support repeated cleaning cycles.
Technical Standards
- ✓ISO 10993-1 / -10 biocompatibility for prolonged skin contact
- ✓ISO 13485-aligned cleanroom production with lot traceability
- ✓Repeated disinfection and cleaning-cycle compatibility data available
- ✓FDA 21 CFR 177.2600 compliant compounds
Manufacturing Process
Cushions and membranes are LSR injection molded in multi-cavity cleanroom tools.
- Low-durometer compounds (20-35 Shore A) with reinforced tear strength
- Membrane valve slits formed flashless in the tool
- Post-cure cycle validated for low residual volatiles
- Skin-contact surfaces molded against polished steel — no post-processing needed
Quality Inspection
- 🔍100% visual inspection (flash, short-shot, contamination) before packing
- 🔍Dimensional verification against approved drawing; FAI report on first shipment and after any tooling change
- 🔍Hardness per ASTM D2240 (Shore A) on every batch
- 🔍Lot traceability: material batch, cure records and operator logged for every carton
- 🔍Membrane crack-pressure and leak test per lot
- 🔍Compression set per ASTM D395 (22 h) for cushion resilience
- 🔍Residual volatile verification on post-cure validation lots
After-sales & Support
Every order ships with a Certificate of Conformance, First Article Inspection report and lot traceability records.
- Warranty: 12 months against material and workmanship defects
- Response: engineering reply within 24 hours, 8D report for confirmed quality issues
- Remedy: free replacement or credit for non-conforming batches; expedited re-shipment at our cost
- Support: free design-for-manufacturing review, material selection advice and sample policy for evaluation
- Recall readiness: full batch traceability enables targeted containment within 48 hours
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