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510(k) Data Aggregation

    K Number
    K221352
    Device Name
    Surgical Face Mask
    Date Cleared
    2023-03-13

    (307 days)

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

    Wuhan Huashida Protective Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
    Device Description
    The Surgical Face Mask is 3-layer, and it is two model is HSD-TYP2R (Ear loops) and HSD-TYP2RT (Tie-On). Flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (spandex and polyester) or tie tapes (spun-bond polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask color is blue. Product is Level 3 based on ASTM F2100-19. The surgical face mask is single-use, disposable devices, provided non-sterile.
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