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

Catalog Number	AVT0680
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon was donning the top glove, his finger pierced through the pinky finger of both gloves and they both sliced through horizontally / ripped in the same location.
Additional Manufacturer Narrative
A complaint was received related to "gloves tearing when donning," and there was no reported death or serious injury associated with this event.From the vendor's review of their batch records and retention samples, no abnormalities or deviations were observed, the lot inspection was completed with passing results, and the review of trending did not indicate that there is a trend of "tearing" or similar occurring in the field.No sample was available for confirmation or further review; the cause was listed as "sample required to determine cause." a review of the complaint information as well as the results of the investigation indicate no need for further action at this time, and complaints are monitored via the trend analysis procedure.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 MICRO,LF,PF,8.0
• 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: 50499062
• Report Number: 1417592-2026-26968
• Device Sequence Number: 9450954
• Product Code: KGO
• UDI-Device Identifier: 10197344099801
• UDI-Public: 10197344099801
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 08/28/2026

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: AVT0680
• Device Lot Number: 4053465280
• 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: 12/03/2025
• Initial Report FDA Received Date: 08/28/2026
• 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