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510(k) Data Aggregation

    K Number
    K203200
    Device Name
    Disposable Medical Surgical Face Mask
    Manufacturer
    Guangdong Haiou Medical Apparatus Co., Ltd.
    Date Cleared
    2021-06-16

    (230 days)

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

    Guangdong Haiou Medical Apparatus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Medical Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.
    Device Description
    Disposable Medical Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device.
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