BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Isolation Gown

    K Number: K223467 · Decision Feb 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    Disposable Isolation Gown
    K Number
    K223467
    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
    Nanning Tecbod Biological Technology Co., Ltd.
    Date Received
    November 17, 2022
    Decision Date
    February 10, 2023
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by Nanning Tecbod Biological Technology Co., Ltd.

    K Number Device Name
    K233068 Disposable Surgical Gown