LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212349
    Device Name
    Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
    Manufacturer
    Medi Legion Sdn.Bhd
    Date Cleared
    2021-12-10

    (135 days)

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

    Medi Legion Sdn.Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder Free White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1