Search Results

If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. including chlamydia infections, genital herpes, genital warts, gonorrhea. hepatitis B, and syphilis. Condoms when properly used are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.

Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

HTL Male Latex Condom, Natural Color, Silicone Lubricated

This document is a 510(k) clearance letter from the FDA for a male latex condom, not a study evaluating device performance or acceptance criteria of an AI/medical device. Therefore, I cannot extract the requested information as it is not present in the provided text.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the general controls and regulations for its product code (85 HIS) and regulatory class (II, 21 CFR 884.5300). However, it does not include details on specific acceptance criteria and a study proving device performance in the format requested.

Ask a specific question about this device