Home » Stronghold Group Receives 510(k) Clearance for Nitrile Examination Gloves
Stronghold Group Receives 510(k) Clearance for Nitrile Examination Gloves
Devices Submissions and Approvals
Stronghold Group has earned the FDA’s 510(k) clearance for its K213859 nitrile medical examination gloves.
The Philadelphia, Pa.-based company, which primarily serves the U.S. federal government, said it plans to produce the gloves in the U.S. and other countries and move its manufacturing base away from China.
The goal is to help relocate the $9 billion a year industry that until now has largely been located in countries such as China and Malaysia, Stronghold said.