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510(k) Data Aggregation

    K Number
    K210897
    Device Name
    Disposable Nitrile Examination Gloves
    Manufacturer
    Shandong DS Safety Technology Co., Ltd.
    Date Cleared
    2021-08-24

    (152 days)

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

    Shandong DS Safety Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.
    Device Description
    The proposed Disposable Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, and is made of nitrile (Acrylonitrile-butadiene copolymer) and chemical additives. It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile.
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