FDA Adverse Event
Malfunction
Summary report: N
GOOD WORKS PERFORMANCE PRO NITRILE EXAM GLOVES
MDR report key: 23369718
·
Received October 23, 2025
Report
- Report Number
- MW5177906
- Event Type
- Malfunction
- Date Received
- October 23, 2025
- Date of Event
- October 13, 2025
- Report Date
- October 20, 2025
- Manufacturer
- AMERICAN NITRILE OPERATIONS LLC
- Product Code
- LZA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
NEW BLUE GLOVES "GOOD WORKS" ARE DANGEROUS TO PROVIDERS PERFORMING NON-STERILE PROCEDURES AND EXAMS. IN THE MIDDLE OF A BLOODY PROCEDURE TODAY, I NOTICED MY THUMB OF THE GLOVE HAD A LARGE TEAR IN IT WITH BLOOD ALL OVER THE GLOVE. I HAD TO STOP THE PROCEDURE, GO WASH MY HANDS AND THEN RETURN PUTTING ON DOUBLE GLOVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1612816 | GOOD WORKS PERFORMANCE PRO NITRILE EXAM GLOVES | POLYMER PATIENT EXAMINATION GLOVE | LZA | AMERICAN NITRILE OPERATIONS LLC | AB250111141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |