(41 days)
The Invigra Condom is used for contraception and for prophylactic 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 syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
Invigra - Male Natural Rubber Latex Condom
The provided document is an FDA 510(k) clearance letter for the INVIGRA Male Latex Condom and does not contain information on acceptance criteria for a device performance study nor a description of such a study. Instead, it confirms the device is substantially equivalent to legally marketed predicate devices.
The document refers to labeling requirements for latex condoms (21 CFR §884.5300 and 21 CFR §801.435) which include an expiration date supported by test data. However, the specific acceptance criteria for these tests, the study design, or the results are not detailed in this document.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence and post-market labeling requirements rather than a detailed performance study with acceptance criteria.
§ 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.