Chiavaye Personal Moisturizer

Chiavaye Personal Moisturizer is an oil-based personal lubricant for penile and/or vaginal application intended to moisturize, lubricate, and enhance comfort during intimate sexual activity. It is a non-sterile, over-the-counter product sold in 30 mL and 100 mL sizes composed of almond oil, coconut oil, grape seed oil, sunflower oil, evening primrose oil, and vitamin E. The product is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.

Chiavaye differs from the predicate (AH! YES OB COCO) in formulation and specifications: it contains almond oil, grape seed oil, and evening primrose oil rather than jojoba seed oil and Dermofeel Viscolid. Both are oil-based, non-sterile, non-water-soluble lubricants with similar viscosity ranges (200–800 cps) and microbial specifications. Both are incompatible with the same condom types. The subject device has specified viscosity and odor parameters whereas the predicate does not.

Testing followed ISO 10993-1 (2023) for biocompatibility, including ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (vaginal irritation), and ISO 10993-11:2017 (acute systemic toxicity). Microbial testing used USP <61> and USP <62>. Condom compatibility was evaluated per ASTM D7661-2023. Shelf-life was assessed by accelerated and real-time age testing.

The subject and predicate devices have the same intended use—to provide lubrication for intimate sexual activity—and substantially similar indications for use and general technological characteristics (oil-based formulation, non-sterile, OTC, same condom incompatibilities, and equivalent microbial specifications). Differences in ingredient formulation and appearance/odor specifications do not raise different safety or effectiveness questions, as demonstrated by biocompatibility testing showing the device is non-cytotoxic, non-irritating, and non-sensitizing.