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510(k) Data Aggregation

    K Number
    K210380
    Device Name
    Medical surgical mask
    Date Cleared
    2021-07-08

    (149 days)

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

    Shantou T&K Medical Equipment Factory Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical surgical 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, provided non-sterile.
    Device Description
    The Medical surgical mask is 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 Medical surgical mask is manufactured with three layers. The outer layer is made of polypropylene (PP) non-woven fabric with blue color. The middle layer is filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene (PP) non-woven fabric with white color. The Medical surgical mask is single use, disposable device, provided non-sterile.
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