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510(k) Data Aggregation

    K Number
    K050689
    Device Name
    SURGICAL FACE MASK
    Date Cleared
    2005-10-26

    (223 days)

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

    CHINA SURGICAL DRESSINGS CENTER CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical masks/Procedure Mask is a high 3 ply face mask is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
    Device Description
    The Surgical Face Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of 3-ply Non-Woven material; inner and outer cover web with middle different filter web sandwiched in between. It covers the nose and mouth of the wearer, and is held in place by tie string or elastic ear loop and a malleable plastic coated wire nose piece. For protection against airborne particles and splatters of blood and saliva…etc
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