Water-based lubricant

Water-based lubricant is a non-sterile personal lubricant for penile, anal, and/or vaginal application intended to moisturize, lubricate, and enhance comfort during intimate sexual activity. It is compatible with natural rubber latex and polyisoprene condoms but not with polyurethane condoms.

The subject device differs from the predicate (ID Free® Personal Lubricant) in formulation ingredients, pH (5.0-6.5 vs 5.0-5.5), osmolality (1-200 vs 250-500 mOsm/kg), viscosity (1-200 vs 2,200-4,400 mPa·s), and shelf-life (3 years vs 2 years). Both are water-soluble, non-sterile, over-the-counter products with the same intended use and condom compatibility profile.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-11:2017 (acute systemic toxicity), ISO 10993-23:2021 (vaginal irritation), ASTM D7661-23 (condom compatibility), and USP standards for viscosity, pH, osmolality, and microbial testing.

The subject and predicate devices have identical intended uses and the same product code (NUC). Although they differ in formulation, pH, osmolality, viscosity, and shelf-life, these differences do not raise different safety and effectiveness questions because they are addressed through comprehensive biocompatibility and performance testing, which demonstrated the subject device is non-cytotoxic, non-irritating, non-sensitizing, and compatible with the same condom types.