(127 days)
The LELO RESPECT HEX Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
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The provided text is a 510(k) clearance letter from the FDA for the "LELO RESPECT HEX Natural Rubber Latex Condom." This document primarily concerns the regulatory approval of a medical device (a condom) and does not contain information about the acceptance criteria, device performance results, or study details (like sample sizes, expert qualifications, or ground truth establishment) typically associated with AI/ML device evaluations.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from this document. The document confirms the device's substantial equivalence to a predicate device for contraception and prophylactic purposes.
§ 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.