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510(k) Data Aggregation

    K Number
    K020865
    Device Name
    ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
    Date Cleared
    2002-05-08

    (51 days)

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

    APL PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
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    K Number
    K990879
    Device Name
    PRE POWDERED LATEX EXAMINATION GLOVES
    Date Cleared
    1999-05-17

    (62 days)

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

    APL PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K990901
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES
    Date Cleared
    1999-05-04

    (47 days)

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

    APL PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    POWDER FREE, LATEX EXAMINATION GLOVES - Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
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