(66 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).
Not Found
The provided document is a 510(k) clearance letter from the FDA for a Dotted Condom, Male Natural Rubber Latex Condom. It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.
The letter explicitly states:
- "Although supporting data is not to be provided in your 510(k) submission, §801.435(j) requires that you maintain this data and that it be available for inspection by FDA."
This indicates that while the manufacturer must have data to support the device's shelf life and performance, this specific FDA clearance letter does not include the details of those studies or acceptance criteria.
Therefore, I cannot provide the requested information from this document.
§ 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.