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510(k) Data Aggregation

    K Number
    K212235
    Device Name
    Surgical Face Mask
    Date Cleared
    2021-12-06

    (140 days)

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

    Shanghai Yunqing Industrial Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical 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. Surgical Face Masks are single use, disposable devices, provided non-sterile.
    Device Description
    Surgical Face Mask contains one model called YOD2001. YOD2001 Surgical Face Mask is in white, barrier level 2, size 173mm*97mm, flat pleated and ear loop type. YQD2001 Surgical Face Mask is a flat pleated type mask composed of three layers. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of polypropylene to provide a firm fit over the nose.
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