Device product
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Z-2230-2026
Product summary
- Firm
- O&M HALYARD INC
- Event
- Event 98805
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 452,500 units
- Official record key
device-enforcement:Z-2230-2026
Official wording
Reason: Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Code information: REF: 48771/UDI: 30680651487712 (Package)20680651487715 (Primary)90680651487714 (Unit of Use) ; 48772/30680651487729 (Package)20680651487722 (Primary)90680651487721 (Unit of Use);48773/30680651487736 (Package)20680651487739 (Primary)90680651487738 (Unit of Use);48774/UDI: 30680651487743 (Package)20680651487746 (Primary) 90680651487745 (Unit of Use);48775/UDI:30680651487750 (Package)20680651487753 (Primary)90680651487752 (Unit of Use)
Distribution pattern: US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
Derived failure modes
-
Unknown
Nitrile Exam Glove failed to meet specifications chemical permeation performance.