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510(k) Data Aggregation

    K Number
    K013774
    Device Name
    CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA
    Manufacturer
    Date Cleared
    2002-03-05

    (112 days)

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

    SUPERMAX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Chlorinated Powder Free Nitrile Medical Examination Gloves with Aloe Vera
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    K Number
    K993864
    Device Name
    COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
    Manufacturer
    Date Cleared
    2000-01-20

    (66 days)

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

    SUPERMAX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder free patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
    Device Description
    Not Found
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    K Number
    K993865
    Device Name
    GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
    Manufacturer
    Date Cleared
    2000-01-20

    (66 days)

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

    SUPERMAX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powdered patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
    Device Description
    GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
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    K Number
    K993258
    Device Name
    SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    Date Cleared
    1999-10-27

    (28 days)

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

    SUPERMAX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A nowder liee patient examination glove is a disposable device made of synthetic material that may bear a tracc annount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
    Device Description
    POWDER FREE NITRILE EXAMINATION GLOVES
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    K Number
    K991415
    Device Name
    SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
    Manufacturer
    Date Cleared
    1999-05-26

    (33 days)

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

    SUPERMAX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." [50 Microgram or less Protein labeling Claim]
    Device Description
    Polymer Coated Powder Free Latex Examination Gloves
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    K Number
    K980966
    Device Name
    SUPERGLOVES POWDERED NITRILE
    Manufacturer
    Date Cleared
    1998-07-22

    (128 days)

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

    SUPERMAX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Powdered Nitrile Examination Gloves
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    K Number
    K980494
    Device Name
    SUPERGLOVES
    Manufacturer
    Date Cleared
    1998-06-09

    (120 days)

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

    SUPERMAX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Latex powdered patient examination gloves with 70 mcgm or less of total water extractable protein per gram
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