(77 days)
The condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
This condom is made of a natural rubber sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth or textured surface, parallel-sided ,reservoir ended condoms with an integral bead at the open end. The nominal length is minimum 180 mm, the width is 52 or 53 +/- 2 mm and 0.03 mm minimum for the thickness.
The provided text is related to a 510(k) submission for male condoms and does not contain information about an AI-powered medical device or a study proving its performance. Therefore, I cannot generate the requested table and study details.
The document is a submission for a new line of flavored latex condoms, seeking substantial equivalence to a previously approved predicate device. It focuses on the physical characteristics, intended use, and technological characteristics of the condom, as well as regulatory compliance.
§ 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.