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

Catalog Number	TRG500M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, while doing an x-ray exam, had 2 different gloves rip open while positioning the patient.The first time was moving the patient's leg for the x-ray positioning, and the glove tore open at the fingertips, the second time was trying to move the patient back in his wheelchair and the entire glove ripped in half at the palm.No blood exposure or any other known exposure in this instance.This is not the first instance gloves have been ripping during use, leaving employees susceptible to blood exposure (i.E.During iv sticksor while taking x-rays), chemical exposure (i.E.While cleaning withpurple top or bleach wipes).
Additional Manufacturer Narrative
It was reported that, while doing an x-ray exam, had 2 different gloves rip open while positioning the patient.The first time was moving the patient's leg for the x-ray positioning, and the glove tore open at the fingertips, the second time was trying to move the patient back in his wheelchair and the entire glove ripped in half at the palm.No blood exposure or any other known exposure in this instance.This is not the first instance gloves have been ripping during use, leaving employees susceptible to blood exposure (i.E.During iv sticksor while taking x-rays), chemical exposure (i.E.While cleaning withpurple top or bleach wipes) 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: FITGUARD
• Common Device Name: GLOVE,EXAM,NITRILE,PF,SELECT,MD
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25266325
• Report Number: 1417592-2026-01652
• Device Sequence Number: 13183099
• Product Code: LZA
• UDI-Device Identifier: 10888277414204
• UDI-Public: 10888277414204
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K222907
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/23/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: TRG500M
• Device Lot Number: MP511103759
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2025
• 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