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510(k) Data Aggregation

    K Number
    K033533
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES
    Date Cleared
    2004-06-24

    (227 days)

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

    APL INTERNATIONAL INCORPORATED LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
    Device Description
    Powder Free Latex Examination Gloves Contains 50 microgram or less of total water Extractable Protein per gram
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    K Number
    K033531
    Device Name
    POWDERED LATEX EXAMINATION GLOVES
    Date Cleared
    2004-03-03

    (114 days)

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

    APL INTERNATIONAL INCORPORATED LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
    Device Description
    Powdered Latex Examination Gloves Contains 200 microgram or less of total water Extractable Protein per gram
    Ask a Question

    Ask a specific question about this device

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