Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K092160
    Device Name
    POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES
    Date Cleared
    2009-11-27

    (134 days)

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

    COMFORT RUBBER GLOVES IND. SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
    Device Description
    POWDER FREE NITRILE (DARK BLUE ) EXAMINATION GLOVES
    Ask a Question

    Ask a specific question about this device

    K Number
    K083624
    Device Name
    POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
    Date Cleared
    2009-02-10

    (64 days)

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

    COMFORT RUBBER GLOVES IND. SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
    Device Description
    POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1