Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)

Water-soluble Personal Lubricant is a non-sterile, water-based lubricant for penile and/or vaginal application designed to enhance comfort during intimate sexual activity. Available in four flavors (Vitamin E, Caramel, Peach, Strawberry), it is packaged in 100-gram PE bottles and is not compatible with natural rubber latex, polyurethane, or polyisoprene condoms.

The subject device differs from the predicate in formulation (uses potassium sorbate, sodium benzoate, and sodium lactate versus propylene glycol, carbomer, and phenoxyethanol), viscosity (4,500–6,500 cps versus 100–300 cps), osmolality (800–1,350 versus 750–950 mOsm/kg), and pH (4.5–6.0 versus 5.5–7.5). Both are water-based, over-the-counter, non-sterile, non-contraceptive lubricants with identical microbial limits and condom compatibility statements.

Biocompatibility testing per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (guinea pig sensitization), ISO 10993-23:2021 (vaginal irritation), and ISO 10993-11:2017 (acute systemic toxicity). Device specifications validated using USP<791> (pH), USP<912> (viscosity), USP<785> (osmolality), USP<51> (antimicrobial effectiveness), USP<61> (microbial counts), and USP<62> (pathogenic organisms).

The subject and predicate devices share identical indications for use and intended purpose (lubrication during intimate activity), are both water-based over-the-counter personal lubricants, and meet the same microbial safety standards and condom compatibility requirements. Although the devices have different formulations and specifications (viscosity, pH, osmolality), the submission argues these differences do not raise different safety or effectiveness questions because biocompatibility testing demonstrates the subject device is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic, and all specifications remained stable throughout the 3-year shelf life.