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510(k) Data Aggregation
K Number
K171213Device Name
One Touch Condom with BenzocaineDate Cleared
2018-01-12
(262 days)
Product Code
Regulation Number
884.5300Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text from the FDA letter (K171213) does not contain information about the acceptance criteria or a study that proves the device meets those criteria for the "One Touch Condom with Benzocaine."
The text is a standard FDA 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It outlines the regulatory framework, general controls, and other requirements for the manufacturer. It does not include specific performance data, study designs, or acceptance criteria.
Therefore, I cannot provide the requested information based on the input text.
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