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510(k) Data Aggregation

    K Number
    K071209
    Device Name
    MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES
    Manufacturer
    HIGH MOMENTUM SDN BHD
    Date Cleared
    2007-07-25

    (85 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination Latex Powder Free Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Latex Powder Free Examination Gloves

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for "Latex Powder Free Examination Gloves". It does not contain information about acceptance criteria and a study proving a device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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