The Challenge
The brand sourced CPAP mask cushions from a trader whose factory could not provide ISO 10993-5/-10 biocompatibility reports. User complaints about facial skin irritation and silicone odor were mounting, and their US distributor demanded full documentation before the next purchase order. Requirements: Class VI-adjacent skin contact compliance, no perceptible odor, leak-free seal at 4-20 cmH₂O pressure range, and 500-cycle wear validation.
Our Solution
We molded the cushions in a class-100,000 cleanroom using medical-grade platinum-cured LSR with post-cure baking to drive out volatiles, then ran full ISO 10993-5 (cytotoxicity), -10 (sensitization/irritation) testing through an accredited third-party lab, plus a 500-cycle wear simulation and seal-integrity validation across the prescribed pressure range.
Results
- ✅ ISO 10993-5 & -10 biocompatibility reports issued and accepted by the US distributor
- ✅ Odor eliminated after optimized post-cure baking schedule
- ✅ Zero seal leakage validated across 4-20 cmH₂O pressure range
- ✅ OEM agreement signed; 6 SKUs in monthly volume production
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