Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)

The Trojan™ Ultra Ribbed Ecstasy is a natural rubber latex male condom with silicone-based lubricant intended for over-the-counter use. It is designed for contraception and to help prevent the transmission of sexually transmitted infections. The condom features a bulbous shape with ribbed texture and a 3-year shelf life.

The subject device is a natural rubber latex condom lubricated with silicone, with dimensions of 200 ± 10 mm length, 0.095 ± 0.010 mm thickness, and widths of 53 ± 2 mm and 71 ± 2 mm at different points. It contains 800 ± 200 mg of silicone lubricant and meets air burst pressure >1.0 kPa. The predicate device shares the same material, lubricant type, length, and shelf life but has slightly different thickness (0.094 ± 0.010 mm) and width specifications, with unspecified lubricant quantity and performance metrics.

ISO 10993-5:2009/R 2014 (cytotoxicity), ISO 10993-10:2010/R 2014 (sensitization), ISO 10993-23:2021 (vaginal irritation), ISO 10993-11:2017 (acute systemic toxicity), ISO 4074:2015 (natural rubber latex male condoms), and ASTM D3492-16 (rubber contraceptives). Shelf life testing was conducted per 21 CFR 801.435.

Both devices share identical intended uses, material composition (natural rubber latex), lubricant type (silicone), and shelf life duration. The subject device's dimensional and specification differences do not raise different safety or effectiveness questions because they fall within normal product variation for ribbed condoms in this category. Both devices meet the same recognized consensus standards (ISO 4074:2015 and ASTM D3492-16) and demonstrate biocompatibility, with no evidence of cytotoxicity, irritation, sensitization, or systemic toxicity.