Device product
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Z-0317-2022
Product summary
- Firm
- O&M HALYARD INC
- Event
- Event 88846
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,928 cases (5,856,000 gloves)
- Official record key
device-enforcement:Z-0317-2022
Official wording
Reason: All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
Code information: All lots of the following sizes: a. XS, REF 47459, UDI (01)20680651474593 b. S, REF 47460, UDI (01)20680651474609 c. M, REF 47461, UDI (01)20680651474616 d. L, REF 47462, UDI (01)20680651474623 e. XL, REF 47463, UDI (01)20680651474630
Distribution pattern: Worldwide distribution - US Nationwide and the countries of EU/Canada.
Derived failure modes
-
Unknown
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.