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

    Nitrile Exam Gloves (Chemotherapy Drug Tested)

    K Number: K223748 · Decision Jan 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    1
    Review Days
    30

    Basic Information

    Device Name
    Nitrile Exam Gloves (Chemotherapy Drug Tested)
    K Number
    K223748
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    US Medical Glove Company LLC
    Date Received
    December 14, 2022
    Decision Date
    January 13, 2023
    Product Code
    LZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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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