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510(k) Data Aggregation

    K Number
    K993733
    Device Name
    LOVE LOCKERS
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2000-03-20

    (137 days)

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

    The Love Lockers condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.

    Device Description

    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. Instead, the document is a 510(k) summary for a "Latex Condom" called "Love Lockers," outlining its classification, predicate device, description, intended use, and technological characteristics. It also includes an FDA clearance letter for the device.

    Therefore, I cannot provide the requested table, sample sizes, expert information, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information as this data is not present in the provided text.

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