Device Dossier

Basic male condom, Hevea-latex

Device Dossier for Basic male condom, Hevea-latex (Basic male condom, Hevea-latex, Class IIb, sponsor Fk n Water). ARTG record, intended purpose, GMDN…

Intended purpose

This device is a single-use, non-medicated, latex male condom designed to act as a physical barrier to prevent the transmission of semen during sexual intercourse. The condom is intended to reduce the risk of unintended pregnancy and to help prevent the transmission of sexually transmitted infections (STIs), including HIV. The condom is to be unwrapped and rolled onto the erect penis before any genital contact occurs. It should be used consistently and correctly during each act of vaginal, anal, or oral intercourse. The device is intended for use by sexually active individuals seeking a barrier method of contraception and/or protection from STIs. It is suitable for use in a variety of settings, including personal, clinical, and public health environments. The product is typically used in consensual sexual activity between partners. Limitations of the device include the potential for breakage, slippage, or incorrect usage, which can reduce its effectiveness in preventing pregnancy or STI transmission. Latex condoms should not be used by individuals with known latex allergies. The device is not intended to be reused, reprocessed, or used in combination with oil based lubricants, which may degrade the latex material. This condom does not contain medicinal substances, is not electronically active, and does not incorporate software. It functions solely as a mechanical barrier and does not guarantee absolute protection from pregnancy or infection.

TGA Public Summary