(90 days)
The [No particular brand name] condom is used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases )
Latex Condom with Dotted/Ribbed Surface and Contour-walled Shape
This document describes a 510(k) premarket notification for a "Latex Condom with Dotted/Ribbed Surface and Contour-walled Shape" and does not contain information related to an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets those criteria, as typically found in submissions for such AI-driven devices.
The document is a clearance letter from the FDA, confirming substantial equivalence of a condom product to existing legally marketed devices. It primarily discusses regulatory compliance, labeling requirements, and the intended use of the condom for contraception and prevention of sexually transmitted diseases. There is no mention of any AI or machine learning components associated with this 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.