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510(k) Data Aggregation

    K Number
    K170136
    Device Name
    Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
    Date Cleared
    2017-08-25

    (220 days)

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

    SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
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