(90 days)
May be used as a personal lubricant when vaginal dryness causes discomfort. Also eases insertion of tampons.
RepHresh™ Vaginal Gel Personal Lubricant
This document is a 510(k) Substantial Equivalence Determination letter from the FDA for the RepHresh Vaginal Gel™. This letter does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a legally marketed device or, if it has different technological characteristics, these do not raise new questions of safety and effectiveness.
To fulfill your request, I would need a document that describes the clinical performance or validation studies conducted for the RepHresh Vaginal Gel™, which is not provided in these pages.
§ 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.