BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURPLE NITRILE EXAM GLOVE MED 500

    MDR report key: 23633470 · Received November 24, 2025

    Report

    Report Number
    9614175-2025-00002
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 8, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    LZC
    UDI-DI
    10076490711426
    PMA / PMN Number
    K160709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ******CORRECTION******* THIS EMDR WAS INITIALLY SUBMITTED WITH PRODUCT CODE 50602 LISTED IN SECTION D4. THE CORRECT PRODUCT CODE FOR THIS REPORT IS 50483.

    Additional Manufacturer Narrative · 0

    INCIDENT TWO. A REVIEW OF THE DEVICE HISTORY RECORD, ALONG WITH AN EVALUATION OF BOTH RETAINED AND RETURNED GLOVE SAMPLES, REVEALED NO ABNORMALITIES. DONNING AND SIMULATION TESTS WERE PERFORMED ON THESE SAMPLES, AND NO IRRITATION¿SUCH AS BURNING, ITCHING, OR RASH¿WAS OBSERVED AFTER GLOVE USE. ALL PRODUCT QUALITY REQUIREMENTS WERE INSPECTED, CONTROLLED, AND RELEASED IN ACCORDANCE WITH THE APPLICABLE PROCEDURES AND OUTGOING QUALITY ASSURANCE PROCESSES. THE MANUFACTURING OF HALYARD PURPLE NITRILE EXAM GLOVES WAS PERFORMED UNDER CONTROLLED ENVIRONMENTAL CONDITIONS USING VALIDATED SYSTEMS AND ESTABLISHED MITIGATION ACTIONS, AS DEFINED WITHIN THE QUALITY MANAGEMENT SYSTEM. IT IS IMPORTANT TO NOTE THAT OTHER EXTERNAL FACTORS¿SUCH AS RESIDUAL CHEMICALS FROM DETERGENTS OR CLEANERS THAT ARE NOT THOROUGHLY RINSED, AS WELL AS EXPOSURE TO METALS LIKE NICKEL OR CHROMIUM¿CAN CONTRIBUTE TO SKIN IRRITATION OR ALLERGIC REACTIONS. THIS COMPLAINT WAS REVIEWED AND DISCUSSED DURING THE WEEKLY QUALITY MEETING TO ENSURE CONTINUED AWARENESS AND TO REINFORCE MANUFACTURING PRACTICES THAT MAINTAIN THE EXPECTED QUALITY STANDARDS FOR OUR CUSTOMERS. A ROOT CAUSE WAS NOT IDENTIFIED. COMPLAINTS ARE TRACKED AND TRENDED USING A STATISTICAL ANALYSIS TOOL, THERE IS NO TREND FOR RELATED COMPLAINT INCIDENTS IN THE PAST 12 MONTHS; THIS ISSUE APPEARS TO BE ISOLATED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    INCIDENT TWO OF TWO. THE SAMPLE IS AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    2 INCIDENTS HAVE RECENTLY REPORTED ADVERSE REACTIONS ASSOCIATED WITH GLOVE USE. THEY NOTED INCREASED INCIDENCE OF GLOVE TEARING IN THE PALM AREA, EXCESSIVE FLUID RETENTION INSIDE THE GLOVES, AND A NOTICEABLE REDUCTION IN GLOVE MATERIAL THICKNESS, RESULTING IN ACCELERATED LIQUID PENETRATION. THE ONLY SUBSTANCES USED IN CONJUNCTION WITH THE GLOVES, ASIDE FROM MUNICIPAL (CITY) WATER AND VE WATER, INCLUDE AN ENZYMATIC CLEANER SUPPLIED BY (B)(4). ONE EMPLOYEE SOUGHT EVALUATION FROM BOTH THE COMPANY PHYSICIAN AND AN OUTSIDE DERMATOLOGIST AND WAS PRESCRIBED A CORTICOSTEROID CREAM, WHICH PROVIDED SYMPTOM RELIEF. THIS EMPLOYEE IS CURRENTLY UNDERGOING MEDICAL TREATMENT. ADDITIONALLY, FOLLOWING CONSULTATION WITH THE COMPANY PHYSICIAN, SUPPLEMENTARY SKIN CARE PRODUCTS WERE PROVIDED FOR THIS INDIVIDUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262409 PURPLE NITRILE EXAM GLOVE MED 500 PURPLE NITRILE EXAM GLOVES LZC O&M HALYARD, INC. 50483 SM5189ZZZ_31CX 10076490711426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other