(145 days)
For use as a personal lubricant to lubricate condoms and help ease insertion of tampons and douches. For OTC use.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Summer's Eve® Lubricating Jelly." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies. The letter is a regulatory approval document and not a technical study report.
Therefore, I cannot provide the requested information based on the input document. The information in the input pertains to the regulatory clearance of a medical device, not a detailed technical evaluation of its performance against specific acceptance criteria.
§ 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.