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510(k) Data Aggregation

    K Number
    K213703
    Device Name
    Surgical Gown
    Manufacturer
    Wujiang Tutaike Textiles & Finishing Co., Ltd.
    Date Cleared
    2022-03-04

    (100 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Wujiang Tutaike Textiles **& Finishing Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K211077
    Device Name
    Surgical Gown
    Manufacturer
    Wujiang Tutaike Textiles & Finishing Co., Ltd.
    Date Cleared
    2021-10-07

    (178 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Wujiang Tutaike Textiles **& Finishing Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    This product is a new type of SMS breathable non-woven fabric. It consists of collar, gown body and sleeves. The main components of proposed device are: (1)One-piece non-woven fabric Surgical Gown: (2)One-piece helps for better protection and good visuals; (3)Lacing: It is used to tie the belt and fix the shape of the Surgical Gown.
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