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

Catalog Number	AVT0075
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "users noted tearing at the wrist" and "a cst note ripping twice with two separate pairs of gloves in a case.".
Additional Manufacturer Narrative
The reported concern was tearing while donning, and the customer reported that a cst noted ripping twice with two separate pairs of gloves in a case.Medline's investigation included a review of the reported issue along with the samples provided by the account; one glove of the pair in the glove wallet was already torn, the second glove underwent donning and doffing testing and successfully met the acceptance criteria, and the glove was evaluated against the dimensional requirements specified in astm d3577 and was found to be compliant.With the provided sample, medline was able to confirm the reported issue; however, medline was unable to determine the root cause behind the reported issue.A review of inspection records confirmed they met established quality requirements, 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,ADVANTAGE PI,LF,PF,7.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50805945
• Report Number: 1417592-2026-43889
• Device Sequence Number: 13414579
• Product Code: KGO
• UDI-Device Identifier: 10197344099634
• UDI-Public: 10197344099634
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/17/2026

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: AVT0075
• Device Lot Number: 4087614775
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2026
• 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: 01/30/2026
• Initial Report FDA Received Date: 09/17/2026
• 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