MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; GLOVE,EXAM,PF,NITRILE,SMARTGUARD,MEDIUM

Catalog Number	SG312
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: GLOVE,EXAM,PF,NITRILE,SMARTGUARD,MEDIUM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: hnin phyu ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25874503
• Report Number: 1417592-2026-06821
• Device Sequence Number: 15465548
• Product Code: LZA
• UDI-Device Identifier: 00888277172022
• UDI-Public: 00888277172022
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K211604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2026

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: SG312
• Device Lot Number: ME401887184
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown