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510(k) Data Aggregation

    K Number
    K212629
    Device Name
    PP Care Nitrile Examination Gloves
    Manufacturer
    EG Group Product and Services CO., Ltd
    Date Cleared
    2022-05-26

    (280 days)

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

    EG Group Product and Services CO., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    PP CARE Nitrile Examination Gloves are Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from acrylonitrile butadiene rubber. These gloves are blue in color and are powder free.
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