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The subject polyurethane condom has the same intended use as the predicate latex condoms. The condom is used for contraceptive and for prophylactic purposes (hclping to prevent transmission of venereal disease). If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted discases, including chlamydia, genital warts, genital warts, gonorrhea, hepatitis B, and syphilis. No contraceptive can guarantee 100% effectiveness. Any use of the condom for other than vaginal intercourse can increase the potential of damage to the condom. For maximum benefits, it is important to follow the instructions for use that accompany the product. Failure to do so may result in the loss of the benefits of a condom. During intimate contact, lesions and various body fluids can transmit sexually transmitted diseases (STDs); therefore, a new condom should be applied each and every time before any such contact occurs. The condom with spermicidal lubricant combines the use of a condom with a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if erection is lost before withdrawal and some semen spills outside the condom. However, the extent of decreased risk has not been established. A condom with spermicidal lubricant should not be used as a substitute for the combined use of a vaginal spermicide and a condom.

A condom is a sheath which completely covers the penis with a closely fitting membrane in the case of the subject medical device is made The polyurethanc utilized for the TROJAN® Polyurethane of a polyurethane matcrial. Condom is an aliphatic polyurethane. Unlike an aromatic polyurethane, the aliphatic polyurethane utilized for the TROJAN® Condom does not have the inherent danger of forming methylene dianiline (MDA), a known carcinogen, which can be leached from some aromatic polyurethane materials. The condom provides a physical barrier between the penis and vagina thus. when properly used. reducing the risk of exchange of semen, other body fluids, or microorganisms during sexual intercourse. The subject condom is approximately 59 mm in width and approximately 180 mm in length, with a reservoir tip at the closed end and an integral ring (rim) at the open end. The subject condom is one of two versions intended to be marketed - this version with spermicidal lubricant (nonoxynol-9, 8%) and the other with a silicone lubricant. In consumer use studies with heterosexual couples, the subject device was found to have equivalent performance to that of the predicate device with regard to the parameters of breakage and slippage.