Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213848
    Device Name
    Medical nitrile examination gloves (Model: JL001)
    Date Cleared
    2022-03-25

    (105 days)

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

    Guangdong Jiali Pharmaceutical Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical nitrile examination gloves is 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 subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1