Water Solubility Human Body Lubricant

Water Solubility Human Body Lubricant is a non-sterile, over-the-counter personal lubricant for penile, anal, and/or vaginal application. It is intended to moisturize and lubricate to enhance comfort during intimate sexual activity and supplement the body's natural lubrication. The product is compatible with natural rubber latex and polyisoprene condoms but not polyurethane condoms.

The subject device differs from the predicate (Agape Warming Personal Lubricant, K200208) in formulation and several specifications: viscosity 3500–4500 cps vs. 2150–4000 cps; pH 5.6–6.4 vs. 3.4–4.5; and osmolality 100–150 mOsm/kg vs. 575–750 mOsm/kg. Both are water-based, semi-viscous, non-sterile lubricants with the same intended use and condom compatibility profile.

Biocompatibility testing per ISO 10993-1 (2023 FDA guidance), including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021), vaginal irritation (ISO 10993-23:2021), and acute systemic toxicity (ISO 10993-11:2017). Condom compatibility tested per ASTM D7661-2023. Device specifications validated per USP <911>, <791>, <831>, <785>, <61>, <62>, and <51>.

Both devices share the same intended use—providing lubrication for intimate sexual activity—and are both water-based, non-sterile, OTC personal lubricants compatible with latex and polyisoprene condoms. Although the subject device has different formulation and specifications for viscosity, pH, and osmolality, the submission argues these differences do not raise different safety or effectiveness questions because both devices passed equivalent biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity) and condom compatibility testing, and both maintain their specifications over a 3-year shelf-life.