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    K Number
    K021396
    Device Name
    DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2002-05-16

    (14 days)

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

    DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE

    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 Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.

    AI/ML Overview

    1. Acceptance Criteria and Device Performance:

    CharacteristicsStandards (Acceptance Criteria)Device Performance
    DimensionsASTM D 6319 – 00aEIMeets
    Physical PropertiesASTM D 6319 – 00dEIMeets
    Freedom from pinholesASTM D 6319 – 00dEI
    FDA 21 CFR 800.20Meets
    Powder-FreeASTM D 6124 – 01
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