MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE, EXAM, NITRILE, PF, W/ FILM, L

Catalog Number	MG2503
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gloves ripping when putting them on, rips at the top".
Additional Manufacturer Narrative
The customer reported gloves ripping when putting them on and ¿rips at the top¿; the complaint stated the issue did not occur during use and no injury occurred.The account was able to provide a sample of two opened boxes, along with 5 already torn gloves, and thirteen gloves were drawn from the box and tested using visual confirmation, dimensional inspection, donning/doffing test, and grip test.All thirteen gloves passed the visual confirmation and grip test with no abnormalities observed; however, one glove failed the dimensional inspection due to measuring below the required palm thickness specified in astm d6319, and twelve gloves tore during the donning and doffing test.With the provided samples, medline was able to confirm the reported issue, and 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, 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, NITRILE, PF, W/ FILM, L
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50547249
• Report Number: 1417592-2026-29686
• Device Sequence Number: 13354406
• Product Code: LZA
• UDI-Device Identifier: 10197344036592
• UDI-Public: 10197344036592
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171873
• 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): 08/31/2026

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: MG2503
• Device Lot Number: K0E51067131
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2026
• 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: 02/12/2026
• Initial Report FDA Received Date: 09/01/2026
• 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