BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

    K Number: K211547 · Decision Jul 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    2
    Review Days
    57

    Basic Information

    Device Name
    Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
    K Number
    K211547
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edma Group, LLC
    Date Received
    May 19, 2021
    Decision Date
    July 15, 2021
    Product Code
    LZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZA Polymer Patient Examination Glove

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    Other Clearances by Edma Group, LLC

    K Number Device Name
    K211540 Edma Synthetic Nitrile Examination Gloves