MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PROTEXIS; SURGEON'S GLOVES

Model Number	2D73TE70
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently in progress.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that the glove had a left tear into two pieces at the base of the palm during donning.
Additional Manufacturer Narrative
The device history record was reviewed and the lot was inspected and released in compliance with all requirements.The sample was returned for evaluation and a tear in the cuff and finger were observed.Visual inspection, tensile strength, and glove thickness measurements were conducted and all results passed within specifications.A review of complaint trending for the last 12 months did not identify any adverse trend.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: PROTEXIS
• Common Device Name: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23684586
• Report Number: 1423537-2025-00486
• Device Sequence Number: 9761276
• Product Code: KGO
• UDI-Device Identifier: 10885380024887
• UDI-Public: (01)10885380024887(17)271031(10)TS24110255
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K031301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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 Model Number: 2D73TE70
• Device Catalogue Number: 2D73TE70
• Device Lot Number: TS24110255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown