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510(k) Data Aggregation

    K Number
    K991049
    Device Name
    CLIMAX
    Manufacturer
    MEDILATEX SDN. BHD.
    Date Cleared
    1999-06-15

    (77 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K923012
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CLIMAX condom is used for contraception and for prophylactic purposes( to help prevent pregnancy and the transmission of sexually transmitted diseases).

    Device Description

    CLIMAX Male Natural Rubber Latex Condom

    AI/ML Overview

    The provided text is related to an FDA 510(k) clearance for "CLIMAX Male Latex Condoms". It does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML medical device.

    Therefore, I cannot provide the requested information from the text. The document is a regulatory clearance letter, not a device performance study report.

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