MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP DIGNITY HEALTH NITRILE EXAM GLOVES; DBD-GLOVE, EXAM, NITRILE, DIGNITY, S

Catalog Number	DGN4024
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Many of the gloves are tearing or look to be torn out of the box.
Additional Manufacturer Narrative
Many of the gloves are tearing or look to be torn out of the box.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: DIGNITY HEALTH NITRILE EXAM GLOVES
• Common Device Name: DBD-GLOVE, EXAM, NITRILE, DIGNITY, S
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24717356
• Report Number: 1417592-2026-00261
• Device Sequence Number: 5763238
• Product Code: LZA
• UDI-Device Identifier: 10888277702004
• UDI-Public: 10888277702004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: DGN4024
• Device Lot Number: KOC206038138
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown