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510(k) Data Aggregation

    K Number
    K171782
    Device Name
    Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs
    Manufacturer
    Blue Sail Medical Co.,Ltd
    Date Cleared
    2017-10-12

    (119 days)

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

    Blue Sail Medical Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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. The proposed device was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
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