INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant

INA Moisturizing Intimate Water-Based Personal Lubricant is a non-sterile, water-based personal lubricant intended for penile and/or vaginal application to enhance ease and comfort during intimate sexual activity. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms and is sold over-the-counter in a 90 mL bottle.

The subject device differs from the predicate (Sex Gel, K181078) in several specifications: higher viscosity (8,000–10,400 cps vs. 3,000–5,000 cps), higher pH (4.3–5.3 vs. 4.0–5.0), higher osmolality (1,394–1,428 mOsm/kg vs. 435–535 mOsm/kg), and higher TAMC limit (<100 cfu/g vs. <10 cfu/g). The formulation includes different botanical ingredients (aloe vera, Centella asiatica extracts, sea buckthorn oil) versus the predicate's sorbitol and hydroxyethylcellulose base.

Biocompatibility testing per ISO 10993-1 (2023 FDA guidance), ISO 10993-5:2009/(R)2014 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (vaginal irritation), and ISO 10993-11:2017 (acute systemic toxicity). Condom compatibility per ASTM D7661-10. Microbial testing per USP <61>, <1111>, <51>, and <62>. Shelf-life testing via real-time aging.

Both devices share identical intended use (lubrication during sexual activity), are water-based, over-the-counter, non-sterile personal lubricants with the same shelf life and condom compatibility claims. Although the subject device has different formulation ingredients and varied specifications (pH, osmolality, viscosity, microbial limits), the submitter argues these differences do not raise new safety or effectiveness questions because the subject lubricant passed all required biocompatibility tests (non-cytotoxic, non-irritating, non-sensitizing, non-toxic) and demonstrated condom compatibility equivalent to the predicate.