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510(k) Data Aggregation

    K Number
    K220155
    Device Name
    Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
    Manufacturer
    Motex Healthcare (Anhui) Co., Ltd.
    Date Cleared
    2022-05-23

    (124 days)

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

    Motex Healthcare (Anhui) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
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