BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Medline Open-back Level 3 Protective Gown

    K Number: K233526 · Decision Mar 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    9
    Applicant Total
    29
    Review Days
    125

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    Basic Information

    Device Name
    Medline Open-back Level 3 Protective Gown
    K Number
    K233526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medline Industries, LP
    Date Received
    November 1, 2023
    Decision Date
    March 5, 2024
    Product Code
    QPC
    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
    QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

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