Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K220382
    Device Name
    Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple
    Date Cleared
    2022-04-21

    (70 days)

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

    Jiangsu Bytech Medical Supplies Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
    Device Description
    The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue/black/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: S, M, L, XL. The subject device is non-sterile.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1