MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE, NITRILE, RESTORE OATMEAL, M

Catalog Number	OAT6802
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they were in a code and had to change out their gloves multiple times because their finger tips were coming thru the end of the gloves and they were ripping with extended use during a code.".
Additional Manufacturer Narrative
The customer reported that the gloves were used at their streator facility and that the gloves had to be changed out multiple times because finger tips were coming thru the end of the gloves and they were ripping with extended use during a code.Inspection reports were reviewed, the lot passed inspection for all physical properties per astm standards, and a historical complaint query identified 5 complaints for tearing in the past 12 months; the sample was received at nfd, tearing at the finger tips was replicated, a thin spot at the finger tips was observed, and tearing at the cuff was also noted.The reported problem was confirmed by medline sample evaluation.Based on the vendor¿s root cause analysis, no issues were found during the manufacturing process that could lead to the reported issue, improper handling/storage was mentioned as potential root causes, and the cause code was updated to unknown responsible party/cannot determine cause with received sample.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, NITRILE, RESTORE OATMEAL, M
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913762
• Report Number: 1417592-2026-51833
• Device Sequence Number: 14897477
• Product Code: LZA
• UDI-Device Identifier: 40888277180438
• UDI-Public: 40888277180438
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162819
• 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: OAT6802
• Device Lot Number: AN305142259
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/11/2023
• 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: 09/27/2023
• Initial Report FDA Received Date: 09/28/2026
• 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