MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICARE SLT,LF,PF,7.5

Catalog Number	MSG1575Z
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "yesterday we went thru 17 pairs of gloves that ripped while trying to gown and glove the doctor for our total joint cases yesterday".
Additional Manufacturer Narrative
The customer reported that 17 pairs of gloves ripped while trying to gown and glove the doctor for total joint cases, and they all broke while donning the gloves on the surgeon.The account was able to provide eleven unopen glove wallets to assist in the investigation; thirteen gloves were donned and evaluated, and one glove tore at the cuff while donning during the testing.Additionally, all thirteen gloves were evaluated for measurements of glove thickness, palm width, and overall length, and three gloves did not meet the fingertip thickness requirements, with two measuring 0.42 mm and one measuring 0.41 mm.Based on the complaint details and investigation, medline confirmed the reported issue; the root cause is attributed to a vendor product issue related to the component manufacturing process as the gloves did not meet product specifications, and there has been no change to the reportability decision associated with this complaint.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,7.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50820643
• Report Number: 1417592-2026-44942
• Device Sequence Number: 10697184
• Product Code: KGO
• UDI-Device Identifier: 10884389109663
• UDI-Public: 10884389109663
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 09/17/2026

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: MSG1575Z
• Device Lot Number: 5055757175
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/26/2025
• 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: 12/19/2025
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (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