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

    Comfort Gown, Safewear Gown

    K Number: K213893 · Decision Dec 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    2
    Review Days
    372

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    Basic Information

    Device Name
    Comfort Gown, Safewear Gown
    K Number
    K213893
    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
    Xuchang Zhengde Environstar Medical Products Co., Ltd.
    Date Received
    December 14, 2021
    Decision Date
    December 21, 2022
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Xuchang Zhengde Environstar Medical Products Co., Ltd.

    K Number Device Name
    K192290 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown