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510(k) Data Aggregation

    K Number
    K122131
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
    Date Cleared
    2012-10-17

    (91 days)

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

    MATANG MFG. SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Powder Free Nitrile Examination Glove - Blue (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05
    Device Description
    Powder Free Nitrile Examination Glove - Blue (Chemotherapy)
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    K Number
    K121368
    Device Name
    NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
    Date Cleared
    2012-08-10

    (95 days)

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

    MATANG MFG. SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Colored Nitrile Examination Glove - Powder Free (Blue, Black and White) is a disposable device made of Nitrile latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A colors blue, black and white will be added to the nitrile examination glove in the production process to produce the colored gloves.
    Device Description
    A Colored Nitrile Examination Glove - Powder Free (Blue, Black and White) is a disposable device made of Nitrile latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A colors blue, black and white will be added to the nitrile examination glove in the production process to produce the colored gloves.
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    K Number
    K072614
    Device Name
    MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
    Date Cleared
    2008-04-15

    (211 days)

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

    MATANG MFG. SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A black, powder free and polymer coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A black pigment is added to the latex in the production process to produce the black colored glove.
    Device Description
    Black, Powder Free and Polymer Coated Latex Examination Glove with a Protein Claim of Less Than 50 µg/gm Glove
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    K Number
    K032549
    Device Name
    MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
    Date Cleared
    2003-09-08

    (21 days)

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

    MATANG MFG. SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Powder-Free Polychloroprene Patient Examination Glove
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    K Number
    K012558
    Device Name
    POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
    Date Cleared
    2001-09-17

    (40 days)

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

    MATANG MFG. SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Matang Powder-Free Latex Patient Examination Gloves with Matang - San Protein Content Labeling Claim of 50 Micrograms or less of total water extractable protein per gram.
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    K Number
    K000985
    Device Name
    MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
    Date Cleared
    2000-04-24

    (28 days)

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

    MATANG MFG. SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K982877
    Device Name
    MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
    Date Cleared
    1998-11-30

    (108 days)

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

    MATANG MFG. SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Matang Powder-Free Latex Patient Examination Glove, with Protein Labeling Claim (50 Micrograms or Less)
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