(193 days)
This intimate moisture lotion is indicated to relieve vaginal dryness instance the pleasure of intimacy. It feels and functions like a woman's own moisture. It is NOT A CONTRACEPTIVE.
Very Private® Intimate Moisture
The provided text is a 510(k) clearance letter from the FDA for a device called "Very Private™ Intimate Moisture." This document is not a study report and therefore does not contain information about acceptance criteria, device performance, study design, or expert evaluations.
The letter only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It specifies the product's regulatory class, product code, and indications for use.
Therefore, I cannot provide the requested information as it is not present in the given text.
§ 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.