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

    Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove

    K Number: K201592 · Decision Sep 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    26
    Review Days
    471

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    Basic Information

    Device Name
    Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
    K Number
    K201592
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardinal Health200, LLC
    Date Received
    June 12, 2020
    Decision Date
    September 26, 2021
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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