MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICR PI ORTHO LT,LF,PF,7.0

Catalog Number	MSG9970
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they have had these gloves tearing at the thumb and cuff during a procedure.".
Additional Manufacturer Narrative
The customer explained that they have had these gloves tearing at the thumb and cuff during a procedure; there was no adverse event.The account provided two closed glove wallets, which were opened and evaluated by donning and doffing, and the gloves were measured for thickness, palm width, and overall length from the tip of the middle finger to the cuff; three gloves failed to meet the required product specifications at the fingertip.Although the returned sample did not tear during testing, the thickness of the glove was not within the allotted specifications, and medline was able to confirm the reported issue.Further investigation reveals that the root cause is attributed to a vendor product issue related to the component manufacturing process as the gloves did not meet product specifications; there were no reports of death or serious injury associated with this event.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,SENSICR PI ORTHO LT,LF,PF,7.0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50950816
• Report Number: 1417592-2026-54863
• Device Sequence Number: 13167869
• Product Code: KGO
• UDI-Device Identifier: 10193489029857
• UDI-Public: 10193489029857
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K142941
• 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): 09/29/2026

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: MSG9970
• Device Lot Number: 2109969270
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2025
• 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: 12/01/2025
• Initial Report FDA Received Date: 09/30/2026
• 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