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510(k) Data Aggregation

    K Number
    K023522
    Device Name
    EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR
    Manufacturer
    EVER-MORE LATEX PRODUCTS SDN BHD
    Date Cleared
    2002-11-29

    (39 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 powder-Free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the examiner's hand or finger's for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

    Device Description

    Powder-Free Latex Examination Gloves - Blue Color

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Ever-More Powder-Free Latex Examination Gloves-Blue Color." It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The letter does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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