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510(k) Data Aggregation

    K Number
    K210878
    Device Name
    Surgical Face Mask (Model: CM2006, CM2008, A88)
    Date Cleared
    2021-09-28

    (188 days)

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

    Shenzhen RealTone Medical Appliance Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.
    Device Description
    Surgical Face Mask is a non-sterile, single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the Surgical Face Mask to be secured on user via earloops (model CM2006 and A88) or ties (model CM2008). Earloops are of Chinlon+Spandex Elastic Fiber (model CM2006) and polyester fibre (model A88) and not made with natural rubber latex; and ties are of spun-bond polypropylene and also not made with natural rubber latex. The nose piece is a single galvanize wire, coated by Polyethylene (model CM2006 and CM2008) and aluminum (model A88). All of the materials used in the construction of the surgical face mask are being used in currently marketed devices.
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