Device product
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - 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-2912-2020
Product summary
- Event
- Event 86131
- Status
- Completed
- Classification
- Class II
- Quantity
- 7119625 total
- Official record key
device-enforcement:Z-2912-2020
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: 2D72NT55X Lot #: TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS20010146, TS20020202, TS20040092 Additional Affected lots as of 10/20/20: TS20040247, TS20050050, TS20050051, TS20050261, TS20060112, TS20060113, TS20070125
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.