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510(k) Data Aggregation

    K Number
    K141467
    Device Name
    SURGICAL GOWN
    Manufacturer
    XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L
    Date Cleared
    2015-03-05

    (275 days)

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

    XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical gowns are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    The surgical gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made of soft, air permeable SMS non-woven fabric.
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