BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD SKYBREEZE POWDER-FREE NITRILE EXAM GLOVES M

    MDR report key: 25135106 · Received May 11, 2026

    Report

    Report Number
    3014421917-2026-00010
    Event Type
    Injury
    Date Received
    May 11, 2026
    Report Date
    May 11, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    LZC
    UDI-DI
    30680651473753
    PMA / PMN Number
    K170136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT 1 OF 2. A REVIEW OF THE MANUFACTURING PROCESS FOR SKYBREEZE NITRILE GLOVES CONFIRMS THAT SHANDONG INTCO MEDICAL PRODUCTS CO., LTD. INTRODUCES THESE GLOVES IN ACCORDANCE WITH AN APPROVED AND VALIDATED PROCESS. HALYARD IS THE SPECIFICATION DEVELOPER OF THE GLOVES CONTRACT MANUFACTURED BY SHANDONG INTCO MEDICAL PRODUCTS CO., LTD. ALL RAW MATERIALS USED ARE CONSISTENT WITH THOSE SPECIFIED FOR MEDICAL-GRADE GLOVES. REPORTS OF ALLERGIC REACTIONS ARE CONSIDERED TO REFLECT INDIVIDUAL RISK MANIFESTATIONS DURING GLOVE USE, WITH OCCURRENCES THAT ARE SPORADIC AND VARY FROM PERSON TO PERSON. DUE TO THE NATURE OF NITRILE GLOVE MANUFACTURING WHICH INVOLVES MULTIPLE CHEMICAL FORMULATIONS AND PROCESSING STEPS, TRACE LEVELS OF RESIDUAL CHEMICALS OR SURFACE SUBSTANCES MAY REMAIN. UNDER TYPICAL CONDITIONS OF USE, THESE TRACE SUBSTANCES DO NOT RESULT IN ADVERSE EFFECTS; HOWEVER, IN SENSITIVE INDIVIDUALS, THEY MAY TRIGGER SKIN IRRITATION OR DELAYED HYPERSENSITIVITY REACTIONS. WHILE THE CURRENT MANUFACTURING PROCESS INCORPORATES RISK CONTROL MEASURES SUCH AS FORMULATION OPTIMIZATION, CONTROLLED WASHING PROCESSES, AND FINISHED PRODUCT INSPECTIONS, IT IS NOT POSSIBLE TO COMPLETELY ELIMINATE THE POTENTIAL FOR REACTIONS IN USERS WITH HEIGHTENED SKIN SENSITIVITY THROUGH EXISTING CONTROLS ALONE. A REVIEW OF COMPLAINTS RECEIVED OVER THE PREVIOUS 12 MONTHS (JANUARY¿DECEMBER 2025) DID NOT IDENTIFY ANY TRENDS, CLUSTERS, OR RECURRING REPORTS OF ALLERGY OR SKIN IRRITATION FROM THIS CUSTOMER. IN RESPONSE TO THE CURRENT COMPLAINT, SHANDONG INTCO MEDICAL PRODUCTS CO., LTD. HAS STRENGTHENED ITS INTERNAL CONTROLS BY ENHANCING COMMUNICATION OF SIMILAR CASES AND INCREASING EMPLOYEE AWARENESS REGARDING THE POTENTIAL RISK OF ALLERGIC REACTIONS ASSOCIATED WITH RESIDUAL CHEMICALS IN FINISHED GLOVES. BASED ON THIS COMPREHENSIVE ASSESSMENT, THE ROOT CAUSE IS DETERMINED TO BE A DELAYED-TYPE CONTACT SKIN REACTION. THE REACTION WAS LIKELY CAUSED BY AN INDIVIDUAL ALLERGIC PREDISPOSITION, FIRST-TIME EXPOSURE TO THIS SPECIFIC FORMULATION, AND A WARM, HUMID, AND OCCLUSIVE ENVIRONMENT INSIDE THE GLOVE THAT SOFTENED THE SKIN BARRIER AND INCREASED SENSITIVITY. 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

    AFTER APPROXIMATELY 10 MINUTES OF GLOVE USE, THE WEARER DEVELOPED SIGNIFICANT ITCHING AND REDNESS ON THE HANDS AND DISCONTINUED USE. ALTHOUGH THE WEARER HAS A KNOWN ALLERGIC PREDISPOSITION, NO SIMILAR REACTIONS HAVE BEEN REPORTED WITH NITRILE GLOVES FROM OTHER MANUFACTURERS PREVIOUSLY USED. THE NURSE LATER CONSULTED A DERMATOLOGIST FOR AN UNRELATED CONCERN AND MENTIONED THE REACTION; HOWEVER, NO TREATMENT OR PRESCRIPTION WAS PROVIDED. DOCTOR SUGGESTED FURTHER TESTS, HOWEVER, NURSE DECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525369 HALYARD SKYBREEZE POWDER-FREE NITRILE EXAM GLOVES M NITRILE EXAM GLOVE LZC O&M HALYARD, INC. 47375 UNKNOWN 30680651473753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other