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510(k) Data Aggregation

    K Number
    K120184
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
    Manufacturer
    ENCOMPASS MEDICAL SUPPLIES INC LIMITED
    Date Cleared
    2012-05-02

    (100 days)

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

    ENCOMPASS MEDICAL SUPPLIES INC LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) 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
    The Powder Free Nitrile Examination Glove Class 1 patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.
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