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    K Number
    K013942
    Device Name
    POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2001-12-31

    (32 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)

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

    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.

    AI/ML Overview

    The device in question is the "Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling)", which is a patient examination glove.

    Acceptance Criteria and Device Performance:

    The acceptance criteria for the glove are based on established ASTM standards and FDA regulations. The device's performance is reported to meet all these criteria.

    CharacteristicsStandardsAcceptance CriteriaReported Device Performance
    DimensionsASTM D 3578 - 01Meets ASTM D 3578 - 01Meets
    Physical PropertiesASTM D 3578 - 01Meets ASTM D 3578 - 01Meets
    Freedom from pinholesASTM D 3578 - 01
    FDA 21 CFR 800.20Meets ASTM D 3578 - 01 and FDA 21 CFR 800.20Meets
    Powder-FreeASTM D 6124 - 00
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