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510(k) Data Aggregation

    K Number
    K212645
    Device Name
    AT
    Manufacturer
    AT Glove Engineering SDN. BHD
    Date Cleared
    2021-12-16

    (118 days)

    Product Code
    LZA
    Regulation Number
    880.6250
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    Applicant Name (Manufacturer) :

    AT Glove Engineering SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AT Nitrile Examination Glove Powder Free 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
    AT Nitrile Examination Glove Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are Violet blue in color having Finger Texture and Ambidextrous and are powder free. The product is non-sterile.
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