Sagami Original 002 Polyurethane Male Condom

The Sagami Original 002 Polyurethane Male Condom is a non-latex, lubricated male condom made of polyurethane material. It is designed for contraception and to help reduce the risk of pregnancy and transmission of sexually transmitted infections (STIs). The device comes in three sizes (Slim Fit, Regular, and Large) and has a 5-year shelf life for Slim Fit and Regular versions and 3-year shelf life for Large.

The subject device is made of polyurethane with silicone oil lubrication, similar to the predicate Okamoto 002 condom. Key differences include: reduced mid-body thickness (0.024 ± 0.008 mm vs. 0.028 ± 0.008 mm), multiple width options (55–61 mm vs. 57 mm fixed), variable length options (170–190 mm vs. 180 mm fixed), higher air burst pressure (≥2.0 kPa vs. ≥1.8 kPa), lower air burst volume (≥3.6 dm³ vs. ≥4.0 dm³), and wider lubricant tolerance (400 ± 100 mg vs. 400 ± 40 mg).

ISO 23409:2011 (Male Condoms—Requirements and test methods for synthetic materials), ISO 4074:2015 (Natural rubber latex male condoms), ISO 10993 series (biocompatibility testing including cytotoxicity, sensitization, and vaginal irritation), ISO 29943-1:2017 (clinical slip/break testing), and FDA Guidance for Male Condoms Made from New Material (Non-Latex) from June 1995.

The subject device is substantially equivalent because it has the same intended use, identical polyurethane formulation and silicone lubrication as the predicate, same regulatory classification, and comparable shelf life. Although dimensional and specification differences exist (thickness, width, length, air burst parameters), these differences do not raise different safety or effectiveness questions. Performance testing demonstrates barrier effectiveness, non-cytotoxicity, non-irritation, and low failure rates comparable to or exceeding the predicate and latex control condoms.