MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,NITRILE,FG TOUCH, 300, L

Catalog Number	FG3003
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the large size gloves that we have are of extremely poor quality.Many are torn while still in the box.I am having at least 3-4 torn gloves daily".
Additional Manufacturer Narrative
The reporter described an issue with large gloves and stated the gloves were of "extremely poor quality," with many torn while still in the box and at least 3-4 torn gloves daily.Medline received one returned sample and, when reviewing the sample, the tearing was found at the wrist; no other abnormalities were identified with the glove, and inspection records tied to this sku and lot had passing result confirmed.The reported issue of torn gloves was confirmed, but medline was unable to determine if this is due to a glove defect or improper donning performed by the end user and was unable to further investigate the issue of pre-torn gloves with the sample returned.No other complaints were logged for this lot and no trending was identified, indicating this issue to be an isolated incident; no further investigation into the cause and complaint is warranted.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,NITRILE,FG TOUCH, 300, L
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883987
• Report Number: 1417592-2026-49918
• Device Sequence Number: 9791908
• Product Code: LZA
• UDI-Device Identifier: 00888277362751
• UDI-Public: 00888277362751
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K051378
• 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): 09/24/2026

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: FG3003
• Device Lot Number: CC401899129S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2024
• 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: 11/13/2024
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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