MAUDE Adverse Event Report: O&M HALYARD, INC. PURPLE NITRILE EXAM GLOVE MED 500; PURPLE NITRILE EXAM GLOVES

Model Number	50483
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
******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
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.

• Brand Name: PURPLE NITRILE EXAM GLOVE MED 500
• Common Device Name: PURPLE NITRILE EXAM GLOVES
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD.; 200 moo 8 kanchanavanich road; tambol prik; sadao songkhla, th
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 23633470
• Report Number: 9614175-2025-00002
• Device Sequence Number: 9290250
• Product Code: LZC
• UDI-Device Identifier: 10076490711426
• UDI-Public: 10076490711426
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 50483
• Device Catalogue Number: 50483
• Device Lot Number: SM5189ZZZ_31CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 12/04/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 11/25/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown