Joylux Intimacy Gel (PG3100)

Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application. It is intended to lubricate, moisturize, 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 device contains water, hydroxyethylcellulose, polyquaterium-5, propylene glycol, PEG-45, aloe vera powder, sodium hyaluronate, and geogard ultra as preservatives, with specifications including viscosity of 900–7800 cps, osmolality of 250–420 mOsm/kg, and pH of 4.0–5.0. The predicate has a different formulation with guar gum and botanical extracts, lower viscosity (1800–4500 cps), and lower osmolality (110–140 mOsm/kg), though both share the same pH range and microbial limits.

Biocompatibility testing per ISO 10993-1:2009 and 2023 FDA guidance including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), vaginal irritation (ISO 10993-23), and acute systemic toxicity (ISO 10993-11). Shelf-life testing per ASTM F1980-21 and condom compatibility per ASTM D7661-18. Microbial testing per USP <51>, <61>, and <62>.

Both devices share identical indications for use as water-based personal lubricants for sexual activity with the same condom compatibility profile. Although the formulations and some specifications differ (viscosity and osmolality ranges), the submission argues these differences do not raise different questions of safety and effectiveness because both products met biocompatibility requirements, maintained specifications over shelf-life, and demonstrated equivalent condom compatibility. The predicate device is legally marketed without design-related recalls, establishing a valid basis for comparison.