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510(k) Data Aggregation

    K Number
    K152479
    Device Name
    HG Pro Nitrile Powder Free Examination Gloves
    Manufacturer
    HEALTHY GLOVE CO.,LTD
    Date Cleared
    2016-04-04

    (217 days)

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

    HEALTHY GLOVE CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    HG PRO® Nitrile Powder Free Examination Gloves are substantially equivalent to the Class 1 patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
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