MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP SENSICARE; GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,8.0

Catalog Number	MSG6380
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that concern reported by the surgeon about the inferior quality of the new surgical gloves that are being provided.Per surgeon report, the new required surgical gloves do not function appropriately.They slide down on the forearms allowing strike through of patient blood directly onto the skin of the surgeon's distal forearms.In addition, they are slippery and interfere with tactility and sizes are inconsistent.The fingertips stretch out and become loose while other portions of the glove do not, making for a very poor surgical experience.These gloves are not up to the quality needed for patient care and safety of both patients and or staff and surgeons.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.
Event or Problem Description
It was reported that, concern reported by the surgeon about the inferior quality of the new surgical gloves that are being provided.Per surgeon report, the new required surgical gloves do not function appropriately.They slide down on the forearms allowing strike through of patient blood directly onto the skin of the surgeon's distal forearms.In addition, they are slippery and interfere with tactility and sizes are inconsistent.The fingertips stretch out and become loose while other portions of the glove do not, making for a very poor surgical experience.These gloves are not up to the quality needed for patient care and safety of both patients and or staff and surgeons.

• Brand Name: SENSICARE
• Common Device Name: GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,8.0
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: meghana maddilli ; 3 lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25420703
• Report Number: 1417592-2026-02144
• Device Sequence Number: 15960466
• Product Code: KGO
• UDI-Device Identifier: 10193489000061
• UDI-Public: 10193489000061
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K192820
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2026

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: MSG6380
• Device Lot Number: 5077124580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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