MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICR PI ORTHO LT,LF,PF,8.5

Catalog Number	MSG9985Z
Medical Device Problem Codes	Material Fragmentation (1261); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the gloves are ripping consistently during use" and "after one of the cases today, the dr.Noticed the glove was torn and a piece was missing that they could not find.".
Additional Manufacturer Narrative
The customer reported that the gloves were ripping consistently during use, and after one of the cases, the dr.Noticed the glove was torn and a piece was missing that they could not find.Medline conducted a thorough investigation, which included a review of the reported concern, examination of the returned sample, and comparison against the approved product specification measurements on file; thirteen gloves were drawn from the size 8.5 box and tested using visual confirmation, dimensional inspection, donning/doffing test, and grip test.All thirteen gloves passed all testing methods, with no abnormalities observed, and with the provided samples, medline was unable to confirm the reported issue.The root cause could not be identified, and 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,SENSICR PI ORTHO LT,LF,PF,8.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50668304
• Report Number: 1417592-2026-30964
• Device Sequence Number: 10235208
• Product Code: KGO
• UDI-Device Identifier: 10193489029888
• UDI-Public: 10193489029888
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203538
• 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): 09/01/2026

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: MSG9985Z
• Device Lot Number: 2046493380
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2026
• 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: 02/04/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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