(129 days)
The Remed Preventor Super Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Super Condom has a ribbed and dotted surfaced, contoured shape with reservoir end, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.
The Remed Preventor Super Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Super Condom has a ribbed and dotted surfaced, contoured shape with reservoir end.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for the "Remed Pharma Male Super Duper Rubber Latex Condom," which primarily discusses regulatory aspects, substantial equivalence to predicate devices, and labeling requirements for the product.
Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Details about any study performed to demonstrate device performance. This includes information about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.
- The type of ground truth used.
The letter references relevant regulations and historical information for the product category but does not include the technical performance data or study methodology that would typically be part of a 510(k) submission itself. This letter is the FDA's decision based on a review of such a submission, not the submission itself.
§ 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.