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

    Surgical Masks

    K Number: K212807 · Decision Dec 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    Surgical Masks
    K Number
    K212807
    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
    September 3, 2021
    Decision Date
    December 3, 2021
    Product Code
    FXX
    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
    FXX Mask, Surgical

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    Other Clearances by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

    K Number Device Name
    K214088 Disposable Surgical Gown
    K220133 Sterilization Wraps
    K213029 Nitrile Examination Gloves (Powder free, Blue)
    K141324 HONGYU DISPOSABLE SURGICAL DRAPES
    K120192 DISPOSABLE SURGICAL GOWNS