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510(k) Data Aggregation

    K Number
    K210429
    Device Name
    Disposable Surgical Face Mask
    Date Cleared
    2021-06-02

    (110 days)

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

    Jiangxi Heying Pharmaceutical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Surgical Face Mask 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 a single use, disposable device(s), provided sterile and non-sterile.
    Device Description
    The Disposable Surgical Face Masks are composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of spun-bond nonwoven fabric, and the middle layer is made of melt blown non-woven fabric. The nose clip is made of polyethylene and iron material, ear loop is made of nylon and spandex material. The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5%cm, the length of the ear loop is ≥ 10.0cm. The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.
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