MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; GLOVE,EXAM,PF,NITRILE

Catalog Number	MDSXB7584
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gloves ripping while putting on or during use.Gloves were used with caregiver, so considered a biohazard since it had contact.There was no contact with bodily fluids or hazardous drugs.".
Additional Manufacturer Narrative
It was reported that "gloves ripping while putting on or during use.Gloves were used with caregiver, so considered a biohazard since it had contact.There was no contact with bodily fluids or hazardous drugs." 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.

• Brand Name: MEDLINE
• Common Device Name: GLOVE,EXAM,PF,NITRILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes drive; northfield IL 60093 2753
• Manufacturer Contact: leann gifford ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25437365
• Report Number: 1417592-2026-02226
• Device Sequence Number: 21356136
• Product Code: LZA
• UDI-Device Identifier: 10193489107753
• UDI-Public: 10193489107753
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K051378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: MDSXB7584
• Device Lot Number: CC505456565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown