MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,NITRILE,PF,SELECT,MD

Catalog Number	TRG500M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gloves ripping while donning glove".
Additional Manufacturer Narrative
Medline received a complaint regarding glove,exam,nitrile,pf,select,md; the reported concern was tearing during use, and there were no reports of death or serious injury associated with this event.The investigation included a review of the reported issue along with the samples provided by the account; thirteen gloves were tested using visual confirmation, dimensional inspection, donning/doffing test, and grip test, and all thirteen gloves passed the visual confirmation, donning/doffing test, and grip test with no abnormalities observed, however one glove failed the dimensional inspection as it measured below the required product specification for palm thickness outlined in astm d6319.Based on the complaint details and investigation, medline can confirm the reported issue.The root cause is attributed to a vendor product issue related to the component manufacturing process as the gloves did not meet product specifications.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,NITRILE,PF,SELECT,MD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50772878
• Report Number: 1417592-2026-40484
• Device Sequence Number: 18747545
• Product Code: LZA
• UDI-Device Identifier: 10888277414204
• UDI-Public: 10888277414204
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K211220
• 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): 09/10/2026

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: TRG500M
• Device Lot Number: MP506663201
• Was Device Available for Evaluation?: Yes
• 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: 02/09/2026
• Initial Report FDA Received Date: 09/15/2026
• 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