(130 days)
The Remed Preventor Classic Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Classic is a parallel sided, plain surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.
The Remed Preventor Classic Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Classic is a parallel sided, plain surfaced condom with no color additives.
This document is an FDA 510(k) clearance letter for three brands of male natural rubber latex condoms manufactured by Remed Pharma. It is not a study report or a technical document detailing acceptance criteria and performance data for a medical device in the way you've outlined.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because this document does not contain that level of detail. It is a regulatory approval letter based on a submission that would have contained such data, but the data itself is not present in this letter.
The letter primarily focuses on:
- Confirming the device is substantially equivalent to legally marketed predicate devices.
- Regulatory classification (Class II).
- General controls and specific regulations applicable to the device (e.g., GMP, labeling requirements for expiration dating).
- The intended use of the device itself (contraception and prevention of STDs).
To answer your questions, one would need the actual 510(k) submission and the test reports referenced within, not just the FDA's clearance letter.
§ 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.