MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,6.5

Catalog Number	MSG6365
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that gloves break easily during use, when a small perforation is made, it extends and enlarges along the length of the glove.Mainly breaks in the area of the fingertips are reported.
Additional Manufacturer Narrative
The customer reported gloves breaking during use, with small perforations extending and enlarging along the length of the glove and mainly in the area of the fingertips; there has been no patient or professional affected in terms of their health.No sample was available for review, but images were reviewed; trending was performed over the last 2 years of complaints, the lot inspection was completed with passing results, and the vendor's review of batch records and retention samples found no abnormalities or deviations.The complaint was confirmed via image for tearing of gloves.The cause was updated to unknown/cannot determine cause, and no trending was identified 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,SENSICARE NEOPRENE,LF,PF,6.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50888466
• Report Number: 1417592-2026-50384
• Device Sequence Number: 21509828
• Product Code: KGO
• UDI-Device Identifier: 10193489000030
• UDI-Public: 10193489000030
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192820
• 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): 09/24/2026

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: MSG6365
• Device Lot Number: 503044EB65-2
• Was Device Available for Evaluation?: No
• 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: 10/23/2025
• Initial Report FDA Received Date: 09/24/2026
• 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