MAUDE Adverse Event Report: Medline Industries, LP PRIVATE LABELED FOR CUSTOMER; GLOVE,EXAM,VINYL,PF,200CT,OSFM

Catalog Number	WRX218257V2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gloves rips on bottom everytime she put them on as well rips on fingers.".
Additional Manufacturer Narrative
The customer reported gloves that tore when donning, and no injury was reported.No sample or images were provided for confirmation or further review; the vendor investigation identified no defects or abnormalities within batch records or retention samples, trending did not indicate that there is a trend of 'tearing when donning' or similar occurring in the field, and inspection for this lot was completed with passing results.Based on the results of the investigation, medline was unable to confirm the complaint issue nor that the product failed to meet specifications, and no root cause was identified.No adverse trending identified, and if additional information becomes available this complaint will be reopened, updated, and investigated as necessary.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,VINYL,PF,200CT,OSFM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50524930
• Report Number: 1417592-2026-28522
• Device Sequence Number: 18659198
• Product Code: LYZ
• UDI-Device Identifier: 00311917150970
• UDI-Public: 00311917150970
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K060778
• 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): 08/29/2026

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: WRX218257V2
• Device Lot Number: MG501067185
• 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: 07/30/2025
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown