0.04 ZERO ZERO FOUR Male Latex Condom

The 0.04 ZERO ZERO FOUR Male Latex Condom is a natural rubber latex sheath that completely covers the penis. It is smooth-surfaced, reservoir-tipped, silicone-lubricated, with dimensions of 180 mm length, 54 mm flat width, and 0.042 mm thickness. It is intended for contraceptive and prophylactic purposes to help prevent pregnancy and transmission of sexually transmitted infections.

The subject device differs from the predicate (Mega Big Boy Condom, K140379) in shape (parallel-sided versus flared), length (180 mm versus 200 mm), width (54 mm versus 57 mm), and thickness (0.042 mm versus 0.063 mm). Both share identical indications for use, raw materials (natural rubber latex and silicone lubricant), color (no color), surface texture (smooth), air burst specifications (>1.0 kPa, 17 dm³), water leakage performance (no leakage), and shelf life (5 years).

ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms); ISO 10993-5:2009 (Cytotoxicity); ISO 10993-23:2021 (Vaginal Irritation); ISO 10993-10:2021 (Sensitization); ISO 10993-11:2017 (Acute Systemic Toxicity); 21 CFR 801.435 (Shelf Life/Stability).

Although the devices differ in dimensions and shape, these differences do not raise different safety and effectiveness questions because both devices meet identical critical performance specifications (air burst pressure and volume, water leakage, and shelf life) and have similar indications for use. Biocompatibility testing demonstrates the subject device is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic, supporting equivalence to the predicate.