MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICARE PI,LF,PF,8.0

Catalog Number	MSG9080
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they have 2 boxes of gloves that are splitting/torn in the middle.
Additional Manufacturer Narrative
The complaint description was splitting/torn in the middle, and the customer stated they have 2 boxes of gloves that are splitting/torn in the middle; the issue occur during use was answered no and injury was answered no.The account provided 2 used boxes of gloves to support the investigation, and thirteen gloves were donned and evaluated, including measurements of glove thickness, palm width, and overall length from the tip of the middle finger to the cuff.During testing, no glove tore and all measured dimension remained within specifications; based on the testing performed and the measurement results, medline was not able to confirm the reported issue.Medline was unable to replicate or confirm the issue reported with the provided sample, and as a result, could not identify the root cause; there were no reports of death or serious injury associated with this event.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,SURG,SENSICARE PI,LF,PF,8.0
• 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: 50763405
• Report Number: 1417592-2026-40058
• Device Sequence Number: 21181190
• Product Code: KGO
• UDI-Device Identifier: 10888277347915
• UDI-Public: 10888277347915
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K193217
• 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): 09/14/2026

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: MSG9080
• Device Lot Number: 5024581480
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2025
• 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: 11/19/2025
• 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