(130 days)
The Remed Preventor Double Whooper Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Double Whooper Condom has a ribbed and dotted surfaced, contoured shape with reservoir end, it is used for contraception and to help prevent the transmission of sexually transmitted diseases.
The Remed Preventor Double Whooper Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Double Whooper Condom has a ribbed and dotted surfaced, contoured shape with reservoir end.
This is a 510(k) clearance letter from the FDA for a condom. It does not contain the information requested about acceptance criteria and study details for a medical device's performance. The document 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."
Therefore, I cannot provide the requested information based on the provided 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.