Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212716
    Device Name
    Dermoaroma Disposable Nitrile Examination Glove
    Date Cleared
    2021-12-27

    (122 days)

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

    ChuZhou Harmony Gloves Medical Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dermoaroma Disposable Nitrile Examination Gloveare disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The proposed device is Powder Free Dermoaroma Disposable Nitrile Examination Glove. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1