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510(k) Data Aggregation

    K Number
    K210679
    Device Name
    Medical Face Mask
    Date Cleared
    2022-01-18

    (316 days)

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

    Wuxi Yushou Medical Appliances Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
    Device Description
    The medical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
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