Device product
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
Z-2919-2020
Product summary
- Event
- Event 86131
- Status
- Completed
- Classification
- Class II
- Quantity
- 7119625 total
- Official record key
device-enforcement:Z-2919-2020
Official wording
Reason: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Code information: Item Code: 2D72NT90X Lot #: TS19080275, TS19090162, TS19090231, TS20010216, TS20030153 Additional Affected Lots of as 10/20/20: TS20040290, TS20050032, TS20060107 Additional Affected Lots as of 2/23/21: TS20040344
Distribution pattern: US Nationwide distribution
Derived failure modes
-
Unknown
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.