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

    Surgical isolation gown

    K Number: K212357 · Decision Jan 20, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    6
    Review Days
    175

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    Basic Information

    Device Name
    Surgical isolation gown
    K Number
    K212357
    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
    Wuhan Zonsen Medical Products Co., Ltd.
    Date Received
    July 29, 2021
    Decision Date
    January 20, 2022
    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 Wuhan Zonsen Medical Products Co., Ltd.

    K Number Device Name
    K223600 Sterilization Wrap
    K213601 Surgical Mask
    K213688 Nitrile Examination Gloves (Model: ZMG1351)
    K212861 Surgical Gown, Reinforced Surgical Gown
    K202191 Surgical Mask