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510(k) Data Aggregation

    K Number
    K210267
    Device Name
    Disposable Surgical Mask
    Date Cleared
    2021-07-08

    (157 days)

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

    Xiamen Eagledon Pharmaceutical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
    Device Description
    Disposable Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth to protect the wearer from microorganisms, body fluids and particulates. Disposable Surgical Mask consists of the following materials: Non-woven cloth in the front and back layers, melt-blown cloth in the middle layer, a nose clip and two ear loops in Spandex. The Disposable Surgical Masks are provided non-sterile.
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