MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG, SENSICARE PI GRN,LF,PF,8.0

Catalog Number	MSG9280
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the glove tore during donning.".
Additional Manufacturer Narrative
The reported concern was tearing while donning, and the updated complaint information stated the gloves had a hook-like tear at the bead, but were within the specified thickness.The investigation noted photo received: no, sample received: no, picture / sample evaluation: n/a; inspection records for the reported sku lot were reviewed and the lot passed with no abnormalities noted, and scar and capa records for the glove division were reviewed with no opened scars or capas for the reported sku in the last 24 months.In the absence of a physical sample or high-quality, detailed photos, medline was unable to confirm the presence of a defect during this investigation.The true root cause could not be accurately determined, and the quality team will continue to monitor for trending.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 PI GRN,LF,PF,8.0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870203
• Report Number: 1417592-2026-49025
• Device Sequence Number: 10715169
• Product Code: KGO
• UDI-Device Identifier: 10888277417175
• UDI-Public: 10888277417175
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191915
• 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): 09/23/2026

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: MSG9280
• Device Lot Number: MFV25030028J
• Was Device Available for Evaluation?: Yes
• 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: 01/26/2026
• Initial Report FDA Received Date: 09/23/2026
• 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