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

Catalog Number	OAT6802
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When she would doff the glove, her fingers were covered in patient¿s blood- has happened 3 times now during the extractions even with changing gloves mid-procedure.No tears in the gloves where the blood was (finger pads and under nail once).Which seems to be a porosity issue vs.Tearing (even though these gloves seem to rip frequently).
Additional Manufacturer Narrative
The customer described that when she would doff the glove, her fingers were covered in patient¿s blood, and this had happened 3 times during the extractions even with changing gloves mid-procedure; no tears in the gloves were noted where the blood was.A historical complaint query was performed for the last 12 months, and a trend was not identified; the lot number provided was incorrect, and no sample was available.Due to lack of lot number and sample, the complaint was unable to be confirmed, and the cause was listed as sample required to determine cause.Medline will continue to trend and monitor this item for continued quality assurance, and there was no medical intervention or serious injury reported related to this incident.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: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946517
• Report Number: 1417592-2026-54280
• Device Sequence Number: 10451997
• Product Code: LZA
• UDI-Device Identifier: 40888277180438
• UDI-Public: 40888277180438
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/29/2026

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: 11525240
• 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: 04/27/2023
• Initial Report FDA Received Date: 09/30/2026
• 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