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

Catalog Number	MSG1565
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gloves are ripping when they put on.".
Additional Manufacturer Narrative
A complaint was received related to "tearing when donning" associated with the sensicare pi slt surgical glove; the complaint stated that gloves are ripping when they put on and reported that no injury occurred.Medline performed a complaint history review and trending review, confirmed the lot inspection was completed with passing results, and the vendor reviewed batch records and retention samples with no abnormalities or deviations observed.The reported issue was confirmed via the supplied image, as tearing could be seen at the cuff of the glove; no potential causes of the defect were identified in the vendor complaint investigation summary.No trending was identified at this time, and the review of the complaint information and investigation results 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,SENSICARE SLT,LF,PF,6.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50524024
• Report Number: 1417592-2026-28426
• Device Sequence Number: 10709434
• Product Code: KGO
• UDI-Device Identifier: 10884389109649
• UDI-Public: 10884389109649
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K193217
• 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): 08/29/2026

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: MSG1565
• Device Lot Number: 4060390465
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2025
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/31/2026
• 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