Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)

Sutil Luxe Personal Lubricant is a water-based, over-the-counter personal lubricant available in four formulations (unscented, vanilla, coconut, and mint) for penile and/or vaginal application. It is intended to moisturize, lubricate, and enhance comfort during intimate sexual activity while supplementing natural lubrication. The product is compatible with natural rubber latex and polyisoprene condoms but not polyurethane condoms.

The subject devices differ from the predicate (Desnuda Reflect) in formulation ingredients, viscosity specifications, osmolality ranges, and shelf life (2 years vs. 1 year). Both are water-based, non-sterile personal lubricants with identical condom compatibility profiles and undergo the same types of biocompatibility and microbiology testing, but the subject uses different thickening agents and includes botanical extracts (oat beta glucan, lotus root water) and stevia-based sweetener.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 and ISO 10993-23:2021 (skin irritation and sensitization via HRIPT), ISO 10993-11:2017 (acute systemic toxicity), ASTM D7661-18 (condom compatibility), USP <51> (antimicrobial effectiveness), USP <61> (microbial limits), USP <62> (pathogenic organism absence), and USP general chapters for pH, viscosity, and osmolality.

Both devices share identical indications for use, are water-based OTC personal lubricants with the same condom compatibility profile, and meet the same biocompatibility and microbiology testing requirements. Although formulation ingredients and shelf life differ, the submitter argues these differences do not raise different safety or effectiveness questions because all performance specifications meet established standards and biocompatibility testing confirms non-cytotoxicity, non-irritation, non-sensitization, and lack of systemic toxicity across all variants.