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

Catalog Number	FG3003H
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that every time the dpm attempted to put the glove on it tore.He said the glove felt sticky inside as well.
Additional Manufacturer Narrative
The customer reported that every time the dpm attempted to put the glove on it tore, and the glove felt sticky inside as well.Two boxes were returned for tearing during use with a specific observation of stickiness during donning; several gloves were donned from both boxes provided, and gloves were confirmed to be challenging to don compared to other samples.Based on the results of the investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications, and the cause was cannot determine cause with received sample.A review of the complaint information as well as the results of the investigation indicated no need for further action, 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,EXAM,NITRILE,FG TOUCH, 300, L
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931845
• Report Number: 1417592-2026-52965
• Device Sequence Number: 9589116
• Product Code: LZA
• UDI-Device Identifier: 00888277362751
• UDI-Public: 00888277362751
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 09/29/2026

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: FG3003H
• Device Lot Number: ZIM40417577
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2024
• 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: 09/20/2024
• Initial Report FDA Received Date: 09/29/2026
• 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