(242 days)
Nulatex Natural Male Latex Condom is used for contraception and prophylactic purposes. (To help prevent pregnancy and transmission of sexually transmitted infection)
Not Found
The provided document is an FDA 510(k) premarket notification approval letter for a male latex condom. It does not contain information about the acceptance criteria and study data for a medical device's performance characteristics beyond the general statement of substantial equivalence to predicate devices.
Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document. This kind of information is typically found in the submission package that precedes the approval letter, which is not provided here.
§ 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.