MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG, SENSICARE PI MICRO,LF,PF,7.5

Catalog Number	MSG9675
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the gloves got torn when putting them on.".
Additional Manufacturer Narrative
The reported concern was tearing when donning; the tear occurred at the wrist, and there was a slight delay in patient care due to frequent glove changes.The account provided both a photo and a sample; the photo depicts a glove positioned on the glove bag, with the cuff torn from the glove and additional material missing from the cuff to the palm, and both gloves underwent visual inspection, dimensional evaluation, grip testing, and donning/doffing assessment.During visual inspection, one glove was already torn and was confirmed to match the glove shown in the submitted photo; during donning, the second glove experienced complete separation of the wrist from the palm, and medline can confirm the reported issue.Medline was unable to determine the root cause behind the reported issue; inspection records confirmed they met established quality requirements, and the quality team will continue to monitor for trending.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 MICRO,LF,PF,7.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50533299
• Report Number: 1417592-2026-29085
• Device Sequence Number: 21309922
• Product Code: KGO
• UDI-Device Identifier: 10888277417304
• UDI-Public: 10888277417304
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/31/2026

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: MSG9675
• Device Lot Number: 311183EB75-3
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• 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: 03/18/2026
• Initial Report FDA Received Date: 08/31/2026
• 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