(137 days)
The BANANA Ribbed condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
This condom is made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth surface on the body, curve-sided, reservoir ended, straight six ribbed line at closed end, nominal length, width, thickness condoms with an integral bead at the open end.
This document is a 510(k) summary for a male natural rubber latex condom. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of medical imaging software or AI. Instead, it describes the device, its intended use, and its substantial equivalence to predicate devices based on existing standards for rubber contraceptives.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document focuses on regulatory approval for a condom, not the performance of an AI or software-driven medical 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.