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510(k) Data Aggregation

    K Number
    K210388
    Device Name
    Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color
    Manufacturer
    Mexpo International Inc.
    Date Cleared
    2021-12-13

    (307 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mexpo International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination glove is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319.
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    K Number
    K200847
    Device Name
    Surgical Face Mask
    Manufacturer
    Mexpo International Inc.
    Date Cleared
    2020-04-23

    (23 days)

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

    Mexpo International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non sterile and for single use only.
    Device Description
    The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.
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