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CUPID Brand Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

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This document is an FDA 510(k) clearance letter for CUPID Brand Male Natural Rubber Latex Condoms. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as one would typically find for a novel diagnostic device or AI algorithm.

The 510(k) pathway for condoms relies on demonstrating substantial equivalence to legally marketed predicate devices, meaning the product performs similarly to existing, cleared products. For condoms, this typically involves demonstrating compliance with recognized standards for physical properties, rather than a clinical study with acceptance criteria in the way a diagnostic AI would have.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on regulatory clearance based on substantial equivalence.

If this were a document for a software as a medical device (SaMD) or an AI-powered diagnostic device, the requested information would be crucial for its clearance. However, for a condom, the regulatory requirements and supporting data are different.

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