(295 days)
The Nulatex Male Natural Rubber Latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Male Latex Condom. (No Particular Brand Name) Natural Smooth, Natural Ribbed, Natural Studded(Dotted), Natural 3 in 1, Natural ultrathin, Pink Smooth, Pink Ribbed, Pink Studded(Dotted),Pink 3 in 1, Pink Ultrathin with/or without Strawberry flavored.
The provided text is a 510(k) substantial equivalence determination letter from the FDA for a Male Latex Condom. It does not contain information about acceptance criteria, device performance, or a study report as typically found in submissions for AI/ML-powered medical devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document only confirms that the device is substantially equivalent to legally marketed predicate devices for contraception and prevention of sexually transmitted infections.
§ 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.