BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10-801B-0, NITRILE EXAM GLOVE SMALL

    MDR report key: 22998458 · Received September 8, 2025

    Report

    Report Number
    MW5175755
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 3, 2025
    Manufacturer
    KOSSAN LATEX INDUSTRIES (M) SDN BHD
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) NURSE CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT SEVERAL STAFF MEMBERS HAVE ALLERGIC REACTION TO PRODUCT 10-801B-0, NITRILE EXAM GLOVE. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048153 10-801B-0, NITRILE EXAM GLOVE SMALL POLYMER PATIENT EXAMINATION GLOVE LZA KOSSAN LATEX INDUSTRIES (M) SDN BHD 050141102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown