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510(k) Data Aggregation

    K Number
    K202316
    Device Name
    Medical mask (Model: KKF-1A)
    Date Cleared
    2021-03-03

    (198 days)

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

    Han Zhaoqing Sporting Goods Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
    Device Description
    The Medical mask are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane), and a malleable nosepiece which is placed within the binding for comfort and individualized fit. The mask not made with latex materials, and all materials are being used in currently marketed devices. The mask will be provided in white. The masks are single-use, disposable devices, provided non-sterile.
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    K Number
    K202314
    Device Name
    Procedure face mask (Model: KKF-2A)
    Date Cleared
    2021-01-13

    (149 days)

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

    Han Zhaoqing Sporting Goods Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Procedure face masks are intended to be worn to protect both the patient and healthcare personnel 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(s), provided non-sterile.
    Device Description
    The Procedure face mask is a three-layer, flat-pleated style mask with ear loops and nose piece design for fitting the face mask around the nose and mouth. The proposed device is manufactured with three layers, the inner (Layer #3) and outer (Layer #1) layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of melt-blown polypropylene. The ear loops are made of Polyester & elastane, and the nose piece is made of Malleable polyethylene wire. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. which is made of malleable polyethylene wire. The face masks will be provided in blue. The face masks are sold non-sterile and are intended to be single-use, disposable devices.
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