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510(k) Data Aggregation

    K Number
    K091147
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2009-07-27

    (98 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
    Device Description
    Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Low Dermatitis Potential Tested For Use With Chemotherapy Drugs.
    Ask a Question
    K Number
    K082370
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2008-10-17

    (60 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs.
    Device Description
    Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Tested For Use With Chemotherapy Drugs.
    Ask a Question
    K Number
    K081466
    Device Name
    STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2008-07-30

    (64 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Sterile, Powder Free Nitrile Examination Gloves, Blue
    Ask a Question
    K Number
    K071170
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2007-09-14

    (140 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves, Magenta and White Color, Coated with AlloGel and Powder free Nitrile Examination Gloves, Magenta And White Color
    Ask a Question
    K Number
    K063627
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2007-03-20

    (104 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.
    Device Description
    Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy (Blue)
    Ask a Question
    K Number
    K061724
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2006-07-25

    (36 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves, Grape Scented, Blue and White color
    Ask a Question
    K Number
    K060726
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2006-05-25

    (69 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves, Coated With Cucumber With Glycerine, Blue Color
    Ask a Question
    K Number
    K060724
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2006-05-17

    (61 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves, Black and Gray Color
    Ask a Question
    K Number
    K050122
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2005-04-18

    (89 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Glove (Blue) (This product does not contain Thiuram, and/or Carbamate and/or Thiazole)
    Ask a Question
    K Number
    K050598
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2005-04-07

    (29 days)

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

    SMART GLOVE CORP. SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This davice also provides protection against exposure to certain chemotherapy drugs.
    Device Description
    Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue)
    Ask a Question

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