(90 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 with Vanilla Flavor, 56 mm width
The provided text is a 510(k) clearance letter from the FDA for a male latex condom. It discusses the regulatory classification, general controls, and labeling requirements for the device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or MRMC studies for AI devices.
Therefore, I cannot provide the requested information based on the given input. The document is for a medical device (a condom), not an AI/ML powered device.
§ 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.