MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,PF,NITRILE,SMARTGUARD,SMALL

Catalog Number	SG311
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "staff are saying they look the same, feel and fit different, and are tearing while applying.".
Additional Manufacturer Narrative
The reporter described issues with smart guard exam gloves ripping and stated that staff were saying the gloves look the same, feel and fit different, and are tearing while applying.Medline received samples and was able to observe the reported issue of tear via the supplied image; from the provided 2 samples for evaluation, both samples had acceptable elongation and did not tear prematurely while donning, and after comparing the feel to other gloves from the same manufacturer, there was no noticeable difference.The reported issue was confirmed via the supplied images, but the provided samples did not tear prematurely while donning.The cause code was updated to, supplier error asia (medline brand) machine/automation process error.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,SMARTGUARD,SMALL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50927984
• Report Number: 1417592-2026-52818
• Device Sequence Number: 9734263
• Product Code: LZA
• UDI-Device Identifier: 00884389172028
• UDI-Public: 00884389172028
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/28/2026

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: SG311
• Device Lot Number: ME401887194
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/20/2024
• 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: 08/16/2024
• Initial Report FDA Received Date: 09/29/2026
• 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