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    K Number
    K213448
    Device Name
    Powder Free Nitrile Gloves
    Manufacturer
    St Future International Limited
    Date Cleared
    2022-06-06

    (224 days)

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

    St Future International Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. This device is a disposable product, provided non-sterile.
    Device Description
    The Powder Free Nitrile Gloves are non-sterile disposable patient examination gloves. The gloves are blue and powder free. The Powder Free Nitrile Gloves come in four sizes: Small, Medium, Large, X Large. The Powder Free Nitrile Gloves act as a barrier to prevent contamination between patient and examiner. The device meets all requirements of ASTM D6319-19.
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