Male Latex Condom HA

The Male Latex Condom HA is a natural rubber latex male condom designed for contraceptive and prophylactic purposes, including prevention of sexually transmitted infections. It is a smooth-surfaced, straight-walled, teat-ended condom with water-based lubricant containing hyaluronic acid, measuring 180 mm in nominal length, 53.5 mm in width, and 0.04 mm in thickness.

The subject device differs from its predicate (Extremely Thin 003, ZERO ZERO THREE) primarily in lubricant formulation: it uses water-based lubricant with hyaluronic acid rather than silicone lubricant. The nominal width is slightly different (53.5 ± 2 mm vs. 53.2 ± 2 mm). All other characteristics—material (natural rubber latex), color, shape, surface texture, length, thickness, air burst specifications, water leakage, and shelf life (5 years)—are identical or similar.

ASTM D3492-16 (Standard Specifications for Rubber Contraceptives - Male Condoms), ISO 4074:2015, ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2021 and ISO 10993-12:2021 (Sensitization), ISO 10993-23:2012 (Vaginal Irritation), and ISO 10993-11:2017 (Acute Systemic Toxicity).

The subject device and predicate device have identical indications for use and substantially similar technological characteristics. Testing demonstrates the subject device meets the same air burst, water leakage, and physical performance specifications as the predicate. The lubricant difference (water-based with hyaluronic acid vs. silicone) and minor dimensional variation do not raise different questions of safety and effectiveness. Biocompatibility testing confirms the device is non-irritating, non-sensitizing, and non-cytotoxic.