MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,CHEMO,NITRILE,ALOE,PF,TXT,XS

Catalog Number	PRO31760
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "cst insists that these gloves are not nitrile gloves and they are in fact latex gloves" and "she states that several doctors, nurses, and other personnel's hands are swelling and having an alergic reaction.".
Additional Manufacturer Narrative
According to the customer, when utilizing the gloves they developed "swelling, itching, and redness" on their "hands and wrists," and the customer reported all of the end users who wore the gloves have a "latex allergy." a historical complaint query was performed for the last 24 months and a trend was not identified; two boxes were received, samples were sent to the manufacturer to test latex protein levels, the vendor completed the latex protein test, and latex was not detected.The gloves were worn for a few minutes to test for any irritation or sensitivities caused by the gloves, and medline was unable to replicate the reported issue; the cause was documented as not confirmed with received sample.No root cause was identified, and the investigation documented that the nitrile gloves do not contain latex and were okay to close.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: GLOVE,EXAM,CHEMO,NITRILE,ALOE,PF,TXT,XS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50754428
• Report Number: 1417592-2026-39216
• Device Sequence Number: 9148860
• Product Code: LZA
• UDI-Device Identifier: 40884389965376
• UDI-Public: 40884389965376
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRO31760
• Device Lot Number: AZ312762585
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 09/14/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown