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

Catalog Number	FG3001
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gloves are torn upon removing them from box.".
Additional Manufacturer Narrative
The reported concern was torn in box, and the complaint transcript states that the gloves are torn upon removing them from box.Medline reviewed the reported issue along with three photos and a sample provided by the account; inspection records for the reported sku lot were reviewed and the lot passed with no abnormalities noted, and scar and capa records for the glove division were reviewed with no related records opened within the past 24 months.Based on the provided photos and sample, the reported issue was confirmed.The investigation supports that the issue is associated with the vendor-related manufacturing process; however, a specific root cause could not be conclusively identified based on the information available, and there has been no change to the reportability decision associated with this complaint.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, S
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50756316
• Report Number: 1417592-2026-39547
• Device Sequence Number: 13062215
• Product Code: LZA
• UDI-Device Identifier: 10888277362734
• UDI-Public: 10888277362734
• 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): 09/10/2026

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: FG3001
• Device Lot Number: ZIM508133706
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2026
• 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: 03/16/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (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