MAUDE Adverse Event Report: Medline Industries, LP PRIVATE LABELED FOR CUSTOMER; GLOVE,EXAM,NITRILE,PF,50CT, L

Catalog Number	WRX319600
Medical Device Problem Codes	Structural Problem (2506); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "last box purchased had about 5 individual gloves affected total.Last glove in box had another inside and fingertips were all stuck together while cuff was wadded and unfinished.Another pair had 2-3 fingers that were not closed and another thatr looked unfinished.All unusable.".
Additional Manufacturer Narrative
The customer reported the last box purchased had about 5 individual gloves affected total, with fingertips all stuck together while the cuff was wadded and unfinished, another pair had 2-3 fingers that were not closed, and another looked unfinished; all unusable.Medline quality did not receive a sample or photograph of the reported item for investigation; a review of inspection record found no similar issues noted, a post-market retrospective review of the past 24 months preceding the reported issue found 0 additional complaints of gloves sticking together, and retained samples were reviewed and did not find any gloves that were stuck together or looked "unfinished." the issue is unconfirmed, as no sample nor photographs were made available to review, and the cause was documented as sample required to determine cause.Based on the findings of the quality investigation, no change has been made to the regulatory reportability decision for the complaint.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: PRIVATE LABELED FOR CUSTOMER
• Common Device Name: GLOVE,EXAM,NITRILE,PF,50CT, L
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50730889
• Report Number: 1417592-2026-36767
• Device Sequence Number: 21480637
• Product Code: LZA
• UDI-Device Identifier: 00311917006765
• UDI-Public: 00311917006765
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193555
• 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): 09/10/2026

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: WRX319600
• Device Lot Number: MH306009985
• Was Device Available for Evaluation?: Yes
• 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: 07/29/2024
• Initial Report FDA Received Date: 09/11/2026
• 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