BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRITERION

    MDR report key: 25182154 · Received May 15, 2026

    Report

    Report Number
    3015335034-2006-00001
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 15, 2026
    Manufacturer
    IDEAL QUALITY SDN. BHD.
    Product Code
    LZA
    PMA / PMN Number
    K183287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INITIAL INVESTIGATION, IN-HOUSE TEST SUCH AS GLOVE SURFACE PH TEST, POWDER RESIDUAL AND DONNING TEST SHOWS NO ABNORMALITY IN THE TEST RESULT. IN ADDITION, RETAINED SAMPLE HAVE BEEN SEND TO (B)(6) LABORATORY TO TEST ON CHEMICAL RESIDUE AND NO CHEMICAL RESIDUAL WAS DETECTED. ATTACHMENT 1: GLOVE SURFACE PH TEST, ATTACHMENT 2: POWDER CONTENT TEST ATTACHMENT 3: CHEMICAL RESIDUAL TEST. THE RETAINED SAMPLE HAVE BEEN SENT TO EXTERNAL INDEPENDENT LABORATORY (B)(6.) FOR CHEMICAL RESIDUAL TEST. THE RESULT IS ESTIMATED TO BE OBTAINED WITH A 2-MONTH PERIOD. PHYSICAL PROPERTIES TEST FOR ELONGATION AT BREAK CONDUCTED FOR PRESHIPMENT INSPECTION AND RETAINED SAMPLE SHOW THAT THE GLOVEA ARE IN GOOD CONDITION WHERE IT NOT EASY BREAK IN NORMAL CONDITION AND ABLE TO MEET THE ELONGATION OF BREAK SPECIFICATION UNDER ASTM D6319. UPON RECEIVED RESULT FROM EXTERNAL LABORATORY, FURTHER INVESTIGATION WILL BE CARRY OUT.

    Description of Event or Problem · 0

    THE CUSTOMER CLAIMS THE GLOVES LEFT A CHEMICAL RESIDUE ON THEIR HANDS AND SKIN/EYES TOUCHED AFTER THE GLOVES WERE REMOVED DESPITE HANDWASHING AND SIGNS OF REDNESS, SWELLING AND IRRITATION. THERE WERE ALSO USABILITY CONCERNS REGARDING THE GLOVES. THEY ARE THIN, PRONE TO TEARING, AND SLIPPERY MAKING THEM DIFFICULT TO DON AND USE RELIABLY. THESE CHARACTERISTICS HAD RAISED CONCERNS TO BARRIER PROTECTION AND INFECTION CONTROL DURING PATIENT CARE. THE REACTION WAS SIGNIFICANT ENOUGH FOR DR. (B)(6) NEEDING TO SEEK MEDICAL EVALUATION. SYMPTOMS WERE REPORTED SHORTLY AFTER USE AND WERE LOCALIZED TO AREAS OF CONTACT. THE GLOVES ARE STORED IN ACCORDANCE WITH STANDARD PRACTICE IN A CLEAN, TEMPERATURE CONTROLLED ENVIRONMENT, CONSISTENT WITH MANUFACTURER GUIDANCE. THE CUSTOMER REPORTS THAT THE GLOVES EMITTED A STRONG CHEMICAL ODOR THAT WAS NOTICEABLE TO BOTH STAFF AND PATIENTS. PATIENTS COMMENTED ON THE ODOR AND ASKED WHETHER ALTERNATIVE GLOVES WERE AVAILABLE DURING THEIR TREATMENT. A PREGNANT STAFF MEMBER WAS UNABLE TO TOLERATE THE ODOR AND MANUALLY SORTED THE GLOVES UPON ARRIVAL SO SHE COULD CONTINUE PERFORMING HER JOB DUTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325963 CRITERION NITRILE EXAM GLOVE LZA IDEAL QUALITY SDN. BHD. K0402611A04

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown