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510(k) Data Aggregation

    K Number
    K203776
    Device Name
    Surgical Masks, Model SNN200640 & MN112
    Date Cleared
    2021-03-25

    (87 days)

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

    SQ Medical Supplies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical 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. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Surgical Masks are manufactured with three/four layers. The surgical mask has two models which are SNN200640 and MN12. They are basically the same, the only difference is the SNN200640 has the three layers and MN112 has the fours layers. The Surgical Masks are single use, disposable device, provided non-sterile.
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