MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,NITRILE,FG TOUCH, 300, L

Catalog Number	FG3003
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "these gloves rip easily while putting them on.".
Additional Manufacturer Narrative
The customer reported many reports from staff who had been using fitguard non-sterile gloves and stated that the gloves rip easily while putting them on; no injury was reported.The account provided one unopened box, and thirteen gloves were subjected to visual inspection, dimensional inspection, grip testing, and donning/doffing evaluation; no abnormalities were observed during visual inspection, grip testing, or donning/doffing evaluation, but dimensional testing found that twelve of the thirteen gloves measured 0.07¿0.09 mm, below the minimum palm thickness requirement specified in astm d6319.Based on the complaint details and investigation, medline confirmed the reported issue.Further investigation determined that the complaint is associated with a vendor product issue, as the evaluated gloves did not meet the specified palm thickness requirements.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,FG TOUCH, 300, L
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael mazeska
• MDR Report Key: 50667090
• Report Number: 1417592-2026-33547
• Device Sequence Number: 10152972
• Product Code: LZA
• UDI-Device Identifier: 10888277362758
• UDI-Public: 10888277362758
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051378
• 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): 09/08/2026

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: FG3003
• Device Lot Number: ZIM508132792
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• 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: 03/09/2026
• Initial Report FDA Received Date: 09/08/2026
• 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