MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,PF,NITRILE,SMARTBOX,M

Catalog Number	MDSXB7585
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that gloves tear easily.
Additional Manufacturer Narrative
The customer reported receiving gloves that tore too easily, and there was no reported death or serious injury associated with this event.The complaint information and sample were reviewed; a torn glove was provided, and when donning several gloves, tearing from the cuff was observed.The complaint was confirmed, however, the root cause for the tearing could not be determined from returned samples; the vendor investigation did not result in any findings that indicated the reported issue may have been caused by the vendor¿s manufacturing process, and noted that if premature tearing was occurring, issue with the beading in the process is the root cause.The review of trending did not indicate that there is a trend of "gloves ripped/tear easily" or similar occurring in the field, inspection for this lot was completed with passing results, and based on the results of the investigation medline was unable to confirm the complaint issue or that the product failed to meet specifications.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,PF,NITRILE,SMARTBOX,M
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945558
• Report Number: 1417592-2026-54100
• Device Sequence Number: 9552425
• Product Code: LZA
• UDI-Device Identifier: 10193489107760
• UDI-Public: 10193489107760
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K200960
• 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: MDSXB7585
• Device Lot Number: CC405164315
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2025
• 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: 02/27/2025
• Initial Report FDA Received Date: 09/30/2026
• 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