MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICARE PI,LF,PF,6.0

Catalog Number	MSG9060
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sterile gloves are tearing when being put on.
Additional Manufacturer Narrative
Medline received a complaint regarding glove, surg, sensicare pi, lf, pf, 6.0; the reported concern was tearing when donning, and there were no reports of death or serious injury associated with this event.The investigation included a review of the reported issue along with the samples provided by the account; the photo depicted one glove torn from cuff to palm, with a significant portion of the glove missing, and the sample included one used glove wallet, with both gloves torn from cuff to wrist.With the provided photo and sample, medline was able to confirm the reported issue; inspection records for the reported product lot were reviewed and the lot passed with no abnormalities noted.Further investigation reveals that the root cause is attributed to a vendor product issue related to the component manufacturing process as the tearing is associated to the failure of the poor bead formation.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,LF,PF,6.0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899781
• Report Number: 1417592-2026-51193
• Device Sequence Number: 20290908
• Product Code: KGO
• UDI-Device Identifier: 10888277347878
• UDI-Public: 10888277347878
• 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): 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: MSG9060
• Device Lot Number: 5042161760
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2026
• 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: 11/25/2025
• Initial Report FDA Received Date: 09/25/2026
• 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