(77 days)
The CLIMAX condom is used for contraception and for prophylactic purposes( to help prevent pregnancy and the transmission of sexually transmitted diseases).
CLIMAX Male Natural Rubber Latex Condom
The provided text is related to an FDA 510(k) clearance for "CLIMAX Male Latex Condoms". It does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML medical device.
Therefore, I cannot provide the requested information from the text. The document is a regulatory clearance letter, not a device performance study report.
§ 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.