MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,NITRL,PF,TXT FNGR,S

Catalog Number	FG2501
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the texture is thin, and they are very brittle, tearing easily.".
Additional Manufacturer Narrative
The customer reported that the gloves were "not the same quality as all the previous gloves we have received," with texture "thin," "very brittle," and "tearing easily," and the box had "a lighter color throughout the box." the account provided one used box; thirteen gloves were donned and evaluated, including measurements of glove thickness, palm width, and overall length from the tip of the middle finger to the cuff, and no gloves tore during the donning and doffing testing while all measured dimensions remained within specification.Based on the testing performed and the measurement results, medline was unable to confirm the reported issue, and the root cause could not be identified.There were no reports of death or serious injury associated with this event, 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,NITRL,PF,TXT FNGR,S
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50552760
• Report Number: 1417592-2026-30215
• Device Sequence Number: 10588925
• Product Code: LZA
• UDI-Device Identifier: 10888277170902
• UDI-Public: 10888277170902
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171339
• 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): 09/01/2026

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: FG2501
• Device Lot Number: BG509922964
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/16/2026
• 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: 01/08/2026
• Initial Report FDA Received Date: 09/01/2026
• 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