Lelo Hex Lubricated Natural Rubber Latex Condom

The Lelo Hex Lubricated Natural Rubber Latex Condom is a male condom made of natural rubber latex with a hexagonal texture pattern, designed for contraception and to help prevent pregnancy and sexually transmitted infections. It is packaged in individually sealed foils and intended for over-the-counter use.

The subject device is a straight-walled, textured natural rubber latex condom with nominal dimensions of 190±10 mm length and 54±2 mm width, 0.060±0.010 mm thickness, lubricated with L-Arginine (550±150 mg), with an air burst pressure >1.0 kPa and volume >18.0 L, and a 3-year shelf life. The predicate device has the same dimensions and material but differs in thickness (0.080±0.010 mm), lubricant type (silicone oil), texture (smooth vs. hexagonal), and shelf life (5 years).

ISO 4074:2015 (Natural rubber latex male condom – Requirement and test methods), ASTM D3492-16 (Standard Specification for Rubber Contraceptives), ISO 10993-5:2009/R 2014 (Cytotoxicity), ISO 10993-10:2021 (Sensitization and Vaginal Irritation), and ISO 10993-11:2017 (Acute Systemic Toxicity).

Both devices have identical indications for use (contraception and prophylactic purposes) and are non-sterile, natural rubber latex condoms intended for OTC use. Although the subject device differs in lubricant formulation, texture, thickness, and shelf life, these differences do not raise different questions of safety and effectiveness because the subject device met all physical performance and biocompatibility testing requirements under recognized standards, demonstrating performance equivalent to the predicate.