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510(k) Data Aggregation

    K Number
    K220943
    Device Name
    Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
    Manufacturer
    ECO Medi Glove Sdn.Bhd.
    Date Cleared
    2022-07-19

    (110 days)

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

    ECO Medi Glove Sdn.Bhd.

    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 for use with chemotherapy drug and Fentanyl Test Claim. In addition these gloves were tested for use with Chemotherapy drug and Fentanyl Citrate Tested claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drug and Fentanyl Citrate Tested Claim.
    Device Description
    Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
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