Julva Velvé Water-Based Personal Lubricant

Julva Velvé Water-Based Personal Lubricant is a non-sterile, over-the-counter water-based personal lubricant for penile and/or vaginal application. It is intended to moisturize and lubricate, enhance ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. The product is compatible with natural rubber latex and polyisoprene condoms but incompatible with polyurethane condoms.

Compared to the predicate device (Desnuda Reflect K211998), Julva Velvé differs in formulation, viscosity (2,100–3,900 cps vs. 12,500–25,000 cps), pH (4.0–5.0 vs. 3.5–4.0), osmolality (1000–2000 vs. 250–400 mOSm/kg), appearance (clear liquid vs. gel), and shelf-life (8.5 months vs. 1 year). Both are water-based OTC devices with similar indications and condom compatibility profiles.

Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (vaginal irritation), and ISO 10993-11 (acute systemic toxicity). Condom compatibility tested per ASTM D7661-18. Microbial testing per USP <61> and USP <62>. Antimicrobial effectiveness per USP <51> Category 2.

The subject device and predicate have identical indications for use and intended use, both are water-based personal lubricants compatible with natural rubber latex and polyisoprene condoms. Although formulation and specifications differ (viscosity, pH, osmolality, shelf-life), these differences do not raise different questions of safety and effectiveness. Biocompatibility and condom compatibility testing confirm non-cytotoxic, non-irritating performance equivalent to the predicate.