BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOOD WORKS PERFORMANCE PRO GLOVES

    MDR report key: 24130968 · Received January 21, 2026

    Report

    Report Number
    MW5182533
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 13, 2026
    Report Date
    January 15, 2026
    Manufacturer
    AMERICAN NITRILE OPERATIONS LLC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PURCHASED AND STOCKED GLOVES FOR (B)(6) AND (B)(6) TO BE IN COMPLIANCE WITH THE MAKE PPE IN AMERICA ACT WERE REPORTED AS NOT FUNCTIONING PROPERLY, RIPPING EASILY WITH APPLICATION, NORMAL WEAR, REMOVAL., ETC. STAFF REPORTED THAT MANY GLOVES ARE RIPPING AS THEY ARE PULLING THEM OUT OF THE BOX AND NEED TO BE DISCARDED. SAYRE CLINIC REPORT LOT NUMBERS AO01667 AND AO01532 SIZE MEDIUM. PATIENT CODE: 4582. DEVICE CODE: 1506, 4008. REF REPORT: MW5182534.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188678 GOOD WORKS PERFORMANCE PRO GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA AMERICAN NITRILE OPERATIONS LLC. 72-50602 AO01667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown