(86 days)
The Simplex brand condom is a male contraceptive device, fabricated of natural latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics 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.
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is made of first grade latex material, teatended, single wall and contoured. Its dimensions are: length 170mm minimum, width: 51mm, thickness: 0.04-0.06 mm (single wall), weight: 1.0-1.3 gm/piece
The provided document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a condom, detailing its description, intended use, technological characteristics, and regulatory correspondence from the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device for market clearance, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot extract the requested information from this document.
§ 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.