(55 days)
The Invigra Condom is used for contraception and for prophytic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
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I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The text is a letter from the FDA regarding the 510(k) clearance of the INVIGRA Male Latex Condom and discusses regulatory aspects, labeling requirements, and indications for use, but it does not detail specific performance acceptance criteria or study results.
§ 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.