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510(k) Data Aggregation

    K Number
    K080827
    Device Name
    HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
    Date Cleared
    2008-04-04

    (10 days)

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

    **HANDAN HENGYONG PROTECTIVE **& CLEAN PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 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. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
    Device Description
    Handan HY8510 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the inner and outer cover. The polypropylene melt blown filter media and polyester filter fabric are layered between the inner and outer cover. The head strap is made of polyester elastic(for single head strap) which is circled to the mask. The inside nosepiece is a PU foam. Handan HY9810 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the outer cover, polyester filter fabric used in the inner cover. The polypropylene melt blown filter media is layered between the inner and out cover. The head straps are made of polyester elastic(for double headband) which is welded to the mask. The inside nosepiece is a PU foam. Both items are no - sterilized and only for single use.
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