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510(k) Data Aggregation

    K Number
    K063334
    Device Name
    SHANGHAI GANGHAI MODEL GIKO 1400
    Date Cleared
    2006-12-08

    (32 days)

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

    SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Shanghai Ganghai Model GIKO 1400 Healthcare Particulate Respirator And Surgical Mask is A NIOSH Approved N95 Single use, disposable, LATEX FREE NON-sterile product. It is A NON-Fiberglass, fluid Resistant MASK 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. This device Also meets CDC Guidelines for TB Exposure Control.
    Device Description
    The Shanghai Ganghai Type N95 Healthcare Particulate Respirator and Surgical Mask Model GIKO 1400 is of a duckbill style. It constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of elastic rubber. The inside nosepiece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of plastic coated aluminum.
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