MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP FITGUARD; GLOVE,EXAM,NITRL,PF,TXT FNGR,XL

Catalog Number	FG2504
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, clinical team has complained that 1 out of 4 xl gloves are ripping down the middle when the clinician puts them on.This is causing a risk of blood borne pathogen contamination.Gloves were tossed and new one was tried.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that, clinical team has complained that 1 out of 4 xl gloves are ripping down the middle when the clinician puts them on.This is causing a risk of blood borne pathogen contamination.Gloves were tossed and new one was tried.

• Brand Name: FITGUARD
• Common Device Name: GLOVE,EXAM,NITRL,PF,TXT FNGR,XL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25196106
• Report Number: 1417592-2026-01342
• Device Sequence Number: 16060543
• Product Code: LZA
• UDI-Device Identifier: 10080196170920
• UDI-Public: 10080196170920
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/16/2026

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: FG2504
• Device Lot Number: K0E508772952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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