FDA-Device2020-09-09Class II

PROTEXIS Latex Micro Surgical Gloves Size 6.5 - 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.

Cardinal Health 200, LLC
Hazard

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Sold states
US Nationwide distribution
Affected count
7119625 total
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2914-2020

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