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510(k) Data Aggregation

    K Number
    K202650
    Device Name
    Medical disposable face mask non sterile
    Date Cleared
    2021-03-24

    (191 days)

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

    Guangdong Zhong Ling Industrial Group Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is 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 Medical disposable face mask non sterile is single use, three-layer, flat-folded masks with ear loops and nose piece. The Medical disposable face mask non sterile is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The outer non-woven cloth is blue and is dyed by colorant of Reactive Blue 2, and the inner non-woven cloth is white and is not dyed by colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. 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 Medical disposable face mask non sterile will be provided in blue. The Medical disposable face mask non sterile is sold non-sterile and are intended to be single use, disposable devices.
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