BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOOD WORKS PERFORMANCE PRO NITRILE EXAM GLOVES

    MDR report key: 23370458 · Received October 23, 2025

    Report

    Report Number
    MW5177919
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 14, 2025
    Report Date
    October 20, 2025
    Manufacturer
    AMERICAN NITRILE OPERATIONS LLC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: THE BOSMA GOOD WORKS NON-STERILE EXAM GLOVES VERY POOR QUALITY. THEY COME OUT OF THE BOX WITH DIGITS TORN OR JUST MISSING (THE MISSING PART IS NOT IN THE BOX) MISSING THE CUFF IS MISSING OR TORN. THEY TEAR VERY EASILY. IF THEY DO COME OUT OF THE BOX WHOLE THEY ARE ALSO VERY THIN COMPARED TO THE BOSMA ENTERPRISE HIGH FIVE EXAM GLOVES. BACKGROUND/RISK FACTORS: INFECTION CONTROL RISK ASSESSMENT: POOR QUALITY PRODUCT AS WELL AS A WASTE SINCE GLOVES ARE BEING THROWN AWAY DUE TO BEING DAMAGED BEFORE THEY ARE EVEN USED. BETTER QUALITY PRODUCT IS NEEDED LESS WASTE AND BETTER INFECTION CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612829 GOOD WORKS PERFORMANCE PRO NITRILE EXAM GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA AMERICAN NITRILE OPERATIONS LLC AO01398 1-4-250702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown