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510(k) Data Aggregation

    K Number
    K022572
    Device Name
    NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
    Date Cleared
    2002-11-08

    (98 days)

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

    AR ALLIANCE HEALTHCARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Not Found
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    K Number
    K022619
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES
    Date Cleared
    2002-09-06

    (30 days)

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

    AR ALLIANCE HEALTHCARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    POWDER FREE NITRILE EXAMINATION GLOVES, Blue
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    K Number
    K020838
    Device Name
    ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    Date Cleared
    2002-04-23

    (40 days)

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

    AR ALLIANCE HEALTHCARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    POWDERED FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MIGROGRAM OR LESS).
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    K Number
    K020359
    Device Name
    ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES
    Date Cleared
    2002-03-06

    (30 days)

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

    AR ALLIANCE HEALTHCARE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Not Found
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