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510(k) Data Aggregation

    K Number
    K234097
    Device Name
    Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Date Cleared
    2024-03-27

    (92 days)

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

    Ever Growth (Vietnam) Corporation Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A non-powdered 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 respectively for use with chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    This device, Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is a nitrile non-sterile medical examination glove available in various sizes (from extra-small to extra-large) and packaging configuration. The gloves are non-sterile medical examination gloves, seamless, ambidextrous, five fingered. They are made from proprietary formulations composed of NBR (Nitrile Butadiene Rubber), accelerator, bulking agent, and pigment. In addition, no former release powder or chemical is used in its manufacturing process.
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