510(k) Submission Testing for Water-Based Personal Lubricant
Project Description
MULTIPLE TESTING
We are looking to conduct the following FDA-required tests as part of our 510(k) submission for a personal lubricant product (21 CFR 884.5300):
- Biocompatibility Testing (ISO 10993-5, -10, -11) - Cytotoxicity Sensitization Irritation
- Condom Compatibility Testing (ASTM D7661) - Evaluation for use with natural rubber latex, polyurethane, and polyisoprene condoms
- Osmolality & Viscosity Testing - To confirm compliance with FDA-accepted safety limits
If you have any specific recommendations or additional requirements for FDA compliance, please let us know. We would also appreciate: A quote for these services, the estimated timeline for testing and results delivery, and any sample requirements or additional documentation needed.
Project Information
Number:25-00510
Industry:Consumer Products
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