Sutil Rich Personal Lubricant

Sutil Rich Personal Lubricant is a non-sterile, water-based personal lubricant for penile 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 polyurethane condoms.

The subject device differs from the predicate (Desnuda Reflect) in formulation ingredients, viscosity specifications (30,000–40,000 cps), osmolality range (550–700 mOsm/kg at 1:5 dilution), and shelf-life duration (2 years vs. 1 year). Both are water-based, non-sterile, OTC products with identical intended use and condom compatibility profiles.

ISO 10993-1 (biological evaluation framework), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 and ISO 10993-23:2021 (skin irritation/sensitization), ISO 10993-11:2017 (acute systemic toxicity), USP <791> (pH), USP <911> (viscosity), USP <785> (osmolality), USP <51> (antimicrobial effectiveness), USP <61> (microbial limits), USP <62> (pathogenic organisms), and ASTM D7661-18 (condom compatibility).

The device has identical intended use and same condom compatibility as the predicate. Although formulation ingredients and shelf-life differ, these differences do not raise different questions of safety and effectiveness because the subject device meets all specified performance criteria through comprehensive biocompatibility testing (non-cytotoxic, non-irritating, non-sensitizing, non-toxic), maintained stability across the 2-year shelf-life, and demonstrated condom compatibility via validated test methods.