MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP FITGUARD; FG TOUCH NITRILE EXAM GLOVES, 100CT, SM

Catalog Number	FG100SH
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that while wearing gloves vaseline and betadine were able to soak through the gloves staining hands.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
It was reported that while wearing gloves vaseline and betadine were able to soak through the gloves staining hands.

• Brand Name: FITGUARD
• Common Device Name: FG TOUCH NITRILE EXAM GLOVES, 100CT, SM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nakiya graves ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25231946
• Report Number: 1417592-2026-00422
• Device Sequence Number: 13351381
• Product Code: LZA
• UDI-Device Identifier: 10888277653948
• UDI-Public: 10888277653948
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K173942
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: FG100SH
• 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: 03/27/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown