MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,LATEX,CURAD,PF,SM

Catalog Number	CUR8104
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that gloves are tearing at cuff.
Additional Manufacturer Narrative
The customer reported gloves are tearing at cuff.Samples were evaluated by visual inspection, physical properties test, thickness measurement, and donning test.The complaint was confirmed based on the images, and medline was able to replicate tearing at the cuff; one returned glove was observed with torn defect at the cuff area, with no pinhole found by the vendor.The cause was updated to dc: unknown responsible party - cannot determine cause w/received sample; based on the investigation conducted on the dhr and tests conducted on the returned and retained samples, no abnormality was found that could lead to glove tearing or breaking, and the gloves conformed to the quality requirement.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,LATEX,CURAD,PF,SM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858634
• Report Number: 1417592-2026-48127
• Device Sequence Number: 13250283
• Product Code: LYY
• UDI-Device Identifier: 40080196319184
• UDI-Public: 40080196319184
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161833
• 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): 09/22/2026

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: CUR8104
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2023
• 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: 12/27/2022
• Initial Report FDA Received Date: 09/22/2026
• 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