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

Catalog Number	TRG300L
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the glove cuffs easily ripped, gloves came out split in too and they ripped while wiping patients.".
Additional Manufacturer Narrative
The customer reported that the glove cuffs easily ripped, gloves came out split in two, and they ripped while wiping patients.Medline quality received 1 bx of the reported product; a torn glove was included, confirming the complaint.A functional assessment of the gloves was conducted by performing a donning test.The gloves were donned without issue, no abnormalities or defects were found, and the reported issue of tearing could not be replicated.A root cause could not be determined based on inspection of the samples.There are no known trends for this product lot.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 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 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, PF, LF, 300, L
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858834
• Report Number: 1417592-2026-48149
• Device Sequence Number: 9497856
• Product Code: LZA
• UDI-Device Identifier: 00888277400521
• UDI-Public: 00888277400521
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/22/2026

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: TRG300L
• Device Lot Number: AN402038152
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2024
• 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: 07/26/2024
• Initial Report FDA Received Date: 09/22/2026
• 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