MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SIGNATURE LTX,ESS,LTX,PF,6

Catalog Number	MSG5960
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we had some gloves rip.".
Additional Manufacturer Narrative
A complaint was received related to a "ripping" associated with the signature essential latex surgical glove, and no other information was available from the complainant on the nature of the complaint.Although fedex indicates delivery, sample could not be located at this time; however, the reported issue was confirmed via the supplied images, trending was performed over the last 2 years of complaints, and the vendor reviewed batch records and retention samples with no abnormalities or deviations observed.The complaint issue was confirmed and the product failed to meet specifications via the images provided.Cause was documented as unknown responsible party, with sample required to determine cause; no adverse trending was identified and the investigation indicated no need for further action at this time.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,SURG,SIGNATURE LTX,ESS,LTX,PF,6
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853813
• Report Number: 1417592-2026-47394
• Device Sequence Number: 13245973
• Product Code: KGO
• UDI-Device Identifier: 10888277629721
• UDI-Public: 10888277629721
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183536
• 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): 09/02/2026

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: MSG5960
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2025
• 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: 05/16/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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