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510(k) Data Aggregation

    K Number
    K211808
    Device Name
    Medcare Powder-Free Blue Nitrile Patient Examination Gloves
    Date Cleared
    2022-03-04

    (266 days)

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

    Dongguan Grinvald Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The powder free patient examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over the counter use.
    Device Description
    Medcare Powder-Free Blue Nitrile Patient Examination Gloves are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder- free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in the following sizes: S, M, L, XL.
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