Device product
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - 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-2918-2020
Product summary
- Event
- Event 86131
- Status
- Completed
- Classification
- Class II
- Quantity
- 7119625 total
- Official record key
device-enforcement:Z-2918-2020
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: 2D72NT85X Lot #: TS19060044, TS19060122, TS19060189, TS19080111, TS19080184, TS19080227, TS19090008, TS19090127, TS19100079, TS19100220, TS19110109, TS19110285, TS19110331, TS19120316, TS20050031, TS20050139 Additional Affected Lots as of 10/20/20: TS20050169, TS20050262, TS20060005
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.