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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.

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