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510(k) Data Aggregation

    K Number
    K222813
    Device Name
    Nitrile Examination Gloves
    Date Cleared
    2023-03-16

    (178 days)

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

    Ecoglove Medical Manufacturing Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color have Finger Texture, Ambidextrous, single-use, and are powderfree. The product is non-sterile.
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