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    K Number
    K211319
    Device Name
    Purism Non-Sterile Powder Free Nitrile Examination Gloves
    Manufacturer
    Dezhou Purism Medical Technology Co., Ltd.
    Date Cleared
    2021-08-19

    (111 days)

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

    Dezhou Purism Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Purism Non-sterile Powder Free Nitrile Examination Gloves 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 Purism Non-sterile Powder Free Nitrile Examination Gloves are a non-sterile, powder free, single use, disposable item. The gloves are made from nitrile compound and are blue in color. The gloves are ambidextrous and offered in Small, Medium, Large and X-Large sizes.
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