The Challenge
The OEM’s mouthpieces tore at the bite tabs after a few dive seasons, and their new EU retail partners required ISO 10993-5 cytotoxicity documentation for prolonged mouth contact. Requirements: tear-resistant medical-touch LSR, bite-tab endurance validation (8-hour continuous simulated bite), compatibility with standard 22/25 mm snorkel and regulator bores, and translucent and black color variants.
Our Solution
We molded the mouthpieces in high-tear medical-touch platinum LSR with a redesigned tab root radius, ran ISO 10993-5 cytotoxicity testing and an 8-hour simulated bite endurance rig, and delivered tooling that fits both standard 22 mm and 25 mm bore geometries in two colors from one mold family.
Results
- ✅ ISO 10993-5 cytotoxicity report issued for EU retail onboarding
- ✅ 8-hour bite endurance passed; tab tearing eliminated
- ✅ One mold family covers 22/25 mm bores in 2 colors
- ✅ OEM switched its full mouthpiece line to our factory
Have a similar challenge?
Send us your failed parts, test reports or just the requirement — we will give an engineering assessment free of charge.
Talk to an Engineer →