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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).

Male Latex Condom with Ribbed Surface (No Particular Brand Name)

The provided document is a 510(k) clearance letter for a medical device (male natural rubber latex condom with ribbed surface) and does not describe or contain information about a study to prove the device meets acceptance criteria. It primarily focuses on the FDA's determination of substantial equivalence based on the provided indications for use and regulatory compliance.

Therefore, I cannot provide the requested information for the following reasons:

1. No acceptance criteria or device performance data is presented. The letter does not detail specific performance metrics, thresholds, or results from any tests.
2. No study is described. The document is a regulatory approval letter, not a scientific study report. It states that the device is substantially equivalent to legally marketed predicate devices but does not elaborate on the data or studies supporting this claim in terms of performance metrics.

To answer your request, a document detailing the actual performance testing, results, and acceptance criteria used by the manufacturer (Pleasure Latex Products SDN.BHD.) for their condom would be required. This letter only signifies that the FDA has reviewed the manufacturer's submission (which would have included such data) and deemed it sufficient for market clearance.

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