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510(k) Data Aggregation

    K Number
    K090131
    Device Name
    DS N95 SURGICAL MASKS AND FLAT SURGICAL
    Date Cleared
    2009-04-27

    (96 days)

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

    SHANGHAI DASHENG HEALTH PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DS N95 Surgical Masks DTC3M-1/DTC3B, and flat surgical masks 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
    The DS DTC3M-1 N95 surgical mask is constructed from a polypropylene spunbond used in the outer layer. The non-woven PP micro is the filter media and the Terylene is layered as the inner. The head strap is made of natural rubber(for double head straps) which is stapled to the mask. The inside nosepiece is a soft sponge foam. The DS DTC3B N95 surgical mask is constructed from a polypropylene spunbond used in the outer cover, a polypropylene spunbond used in the inner cover. The non-woven PP micro fiber and polypropylene melt blown filter media is layered between the inner and out cover. The head straps are made of woven elastic strap(for single headband) which is circule to the mask. The inside nosepiece is a EVA micro-aperture foam. The flat surgical masks (colors: blue, green, pink, white, yellow, orange) are flat pleated by 3-ply masks with outer layer and inner layers (spunbonded polypropylene) that sanwich a meltbown non-woven PP micro fibre filter material Ear-loops are made of spandex belt for free elastic loops. The nose piece for all DS Face Masks is malleable wire. Fog free masks have an anti-fog strip. Masks with splash visors have anti-fog treated plastic shield attached to masks,All of the material used in the construction of the DS Surgical Masks are being used in currently marketed devices (see predicate information). All items are no - sterilized and only for single use.
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