MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,NITRL,PF,TXT FNGR,L

Catalog Number	FG2503
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the new purple fit guard gloves are falling apart or ripping while putting them on.They haven't even started their procedure yet." it was also reported that "they have also failed during procedure with our \"dirty\" scopes, so bare hands are now touching the scopes.".
Additional Manufacturer Narrative
The customer reported that the new purple fit guard gloves were falling apart or ripping while putting them on, failed during patient care, and failed during procedure with "dirty" scopes; according to the customer, there have not been any injuries incurred.A historical complaint query was performed for the last 24 months, and a trend was not identified.The complaint could not be confirmed as there was no samples returned, and without a sample, it is difficult to determine a true root cause for the reported issue.Based on the investigation results, no further actions are being taken at this time.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: GLOVE,EXAM,NITRL,PF,TXT FNGR,L
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50933871
• Report Number: 1417592-2026-53292
• Device Sequence Number: 9597968
• Product Code: LZA
• UDI-Device Identifier: 00888277170912
• UDI-Public: 00888277170912
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K171339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: FG2503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown