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510(k) Data Aggregation

    K Number
    K213851
    Device Name
    Disposable Medical Nitrile gloves
    Date Cleared
    2022-03-09

    (89 days)

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

    Guangdong Xingcan Brothers Medical Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Medical Nitrile gloves intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are composed of Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and blue colorant Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and a rolled rim at the cuff edge. The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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