(78 days)
THE [No particular brand name] condom is used for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Male Natural Rubber Latex Condom
This document discusses the FDA's acceptance of a 510(k) premarket notification for a male natural rubber latex condom. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be detailed in the 510(k) submission itself, which this letter is a response to, rather than the approval letter.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth, as none of that information is present in the provided text.
§ 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.