(90 days)
The LifeStyles, Contempo or private label Male Latex Condom with Desensitizing Lubricant is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. Additionally, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.
These condoms are male contraceptive and prophylactic devices fabricated of natural rubber latex with lubricant containing Benzocaine, an over-the-counter drug generally recognized as safe and effective by the U.S. FDA as a male genital desensitizer (21 CFR Part 348 - External Analgesic Drug Products for Over-the-Counter Human Use). The condoms are designed as fitted sheaths with an integral ring at the open end and a reservoir at the closed end to contain semen. These condoms are designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074 and EN 600.
The provided text is a 510(k) summary for a male latex condom with a desensitizing lubricant. It discusses the device's description, intended use, and technological characteristics, and includes the FDA’s response letter. However, it does not contain any information about specific acceptance criteria or the results of a study designed to prove the device meets such criteria.
The document states that the condoms are "designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074 and EN 600." While these standards include performance requirements for condoms, the specific acceptance criteria (e.g., burst pressure, freedom from holes) the sponsor used for this particular submission are not listed, nor are the results of any testing against these criteria presented in this summary.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details from the text provided.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.