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The Remed Preventor Banana Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Banana Tutti Frutti condom is a parallel sided, plain surfaced condom with banana flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Banana Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Banana Tutti Frutti condom is a parallel sided, plain surfaced condom with banana flavor and no color additives.

The provided documents are regulatory approval letters and indication for use statements for "Remed Pharma Male Coconut Tutti Frutti Natural Rubber Latex Condom" and "Remed Pharma Male Banana Tutti Frutti Natural Rubber Latex Condom." They do not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details to prove the device meets them from the provided text. The documents indicate the devices are substantially equivalent to previously marketed predicate devices and thus permitted to proceed to market under general controls. There is no mention of specific performance studies or their associated metrics.

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