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510(k) Data Aggregation

    K Number
    K170094
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
    Manufacturer
    Viet Glove Corporation
    Date Cleared
    2017-06-23

    (163 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Viet Glove Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Powder Free Latex Examination Glove, Polymer Coated
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    K Number
    K162175
    Device Name
    Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
    Manufacturer
    Viet Glove Corporation
    Date Cleared
    2016-11-21

    (110 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Viet Glove Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Powder Free Latex Examination Glove with Protein Labeling Claim of 50 ug/dm2 or less
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    K Number
    K153562
    Device Name
    Powder Free Blue Nitrile Examination Glove
    Manufacturer
    Viet Glove Corporation
    Date Cleared
    2016-04-01

    (109 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Viet Glove Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    POWDER FREE BLUE NITRILE EXAMINATION GLOVE
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