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510(k) Data Aggregation

    K Number
    K232797
    Device Name
    Hygenix
    Manufacturer
    Shenzhen Hygenix Industrial Co., Ltd
    Date Cleared
    2023-12-11

    (90 days)

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

    Shenzhen Hygenix Industrial Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hygenix is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms. body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.
    Device Description
    The Hygenix is a 3 Ply flat- pleated and Disposable surgical mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PC coated Aluminium wire. The model ear loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of Polyester and Spandex. The dimensions of the Mask are: length- 175 ± 5 mm and width- 95 ± 5 mm. These masks are single-use, disposable devices, provided non-sterile.
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