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510(k) Data Aggregation

    K Number
    K991493
    Device Name
    BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    MASJU SDN. BHD.
    Date Cleared
    1999-05-26

    (28 days)

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

    MASJU SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A blue powder-free medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.
    Device Description
    Blue Powder-Free Nitrile Examination Gloves
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    K Number
    K980150
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    MASJU SDN. BHD.
    Date Cleared
    1998-02-09

    (24 days)

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

    MASJU SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.
    Device Description
    POWDER-FREE NITRILE EXAMINATION GLOVES
    Ask a Question

    Ask a specific question about this device

    K Number
    K980149
    Device Name
    POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    MASJU SDN. BHD.
    Date Cleared
    1998-01-29

    (13 days)

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

    MASJU SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.
    Device Description
    Powdered Nitrile Examination Gloves
    Ask a Question

    Ask a specific question about this device

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