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

    Disposable Surgical Gown

    K Number: K214088 · Decision Apr 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    6
    Review Days
    105

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    Basic Information

    Device Name
    Disposable Surgical Gown
    K Number
    K214088
    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
    Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
    Date Received
    December 28, 2021
    Decision Date
    April 12, 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 Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

    K Number Device Name
    K220133 Sterilization Wraps
    K213029 Nitrile Examination Gloves (Powder free, Blue)
    K212807 Surgical Masks
    K141324 HONGYU DISPOSABLE SURGICAL DRAPES
    K120192 DISPOSABLE SURGICAL GOWNS