(22 days)
The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Male Natural Rubber Latex Condom
This is a 510(k) clearance letter for a Male Natural Rubber Latex Condom, not a study describing the approval of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment for an AI/ML device is not applicable and cannot be extracted from the provided text.
The document discusses the regulatory clearance process for a medical device (condom) based on its substantial equivalence to a predicate device, and it outlines general regulatory requirements under the Federal Food, Drug, and Cosmetic Act.
§ 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.