MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,PF,NITRILE,SMARTBOX,M

Catalog Number	MDSXB7585
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that glove ripped.
Additional Manufacturer Narrative
Customer reported: "glove ripped"; "was there injury? n0 - error occurred but did not reach the individual." the account was able to provide a sample of an already torn glove; no unused samples were provided for additional testing, and the glove was evaluated for fingertip, palm, and cuff thickness.Measurements for length and width could not be obtained because the glove was torn in half, and all measured thickness values were found to be within the applicable product specifications outlined in astm d6319.With the provided sample, medline confirmed the reported issue; however, medline was unable to determine the root cause, 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,EXAM,PF,NITRILE,SMARTBOX,M
• 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: 50826323
• Report Number: 1417592-2026-45286
• Device Sequence Number: 10696888
• Product Code: LZA
• UDI-Device Identifier: 10193489107760
• UDI-Public: 10193489107760
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K200960
• 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: MDSXB7585
• Device Lot Number: ZIM302813510
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2026
• 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: 01/26/2026
• Initial Report FDA Received Date: 09/18/2026
• 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