MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; SURGEONS GLOVES

Model Number	MSG6380
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon reported that the new gloves are unacceptable.They have a slimy texture that makes it difficult to tie knots.The cuffs are too loose and work their way down while operating.They have a truly offensive odor.

• Brand Name: MEDLINE
• Common Device Name: SURGEONS GLOVES
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 25113933
• Report Number: 25113933
• Device Sequence Number: 9321479
• Product Code: KGO
• UDI-Device Identifier: 10193489000061
• UDI-Public: (01)10193489000061
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026
• Report Date (Section F): 04/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: MSG6380
• Device Catalogue Number: MSG6380
• Device Lot Number: 5077124580
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/29/2026