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510(k) Data Aggregation

    K Number
    K220487
    Device Name
    Disposable Medical Face Mask
    Date Cleared
    2022-04-26

    (63 days)

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

    Hubei Mediunion Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Medical 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 is a single use, disposable device(s), provided non-sterile.
    Device Description
    The Disposable medical face mask is designed for single-use and should be disposed of properly after one wear. The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering. This is a single use, disposable device(s), provided non-sterile.
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