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510(k) Data Aggregation

    K Number
    K072067
    Device Name
    N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
    Date Cleared
    2008-01-08

    (165 days)

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

    SHUENN BAO SHING CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The N95 Surgical Respirator AP0018 and AP0028 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
    Device Description
    SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearer's nose. No fiberglass media is used in this product.
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