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    K Number
    K012969
    Device Name
    DOUBLE SPRINGERS NONOXNOL 9 CONDOM
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2002-06-12

    (281 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DOUBLE SPRINGERS NONOXNOL 9 CONDOM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Double Springers Nonoxynol 9 condom, is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA to Medtech Products Limited regarding the substantial equivalence of their "Double Springers Nonoxynol 9 Lubricated Condom." This document is an FDA clearance letter and does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it meets the regulatory requirements for marketing. However, it does not describe the specific performance characteristics or the studies conducted to demonstrate those characteristics.

    Therefore, I cannot provide the requested table and study details based on the given input.

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