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510(k) Data Aggregation

    K Number
    K171213
    Device Name
    One Touch Condom with Benzocaine
    Manufacturer
    Thai Nippon Rubber Industry Public Company Limited
    Date Cleared
    2018-01-12

    (262 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    One Touch Condom with Benzocaine

    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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