TAIJI Medical Supplies Gets FDA’s 510(k) Clearance for Surgical Face Mask

Lincolnton, N.C.-based TAIJI Medical Supplies has received 510(k) marketing clearance from the FDA for its Professional Series Level 3 surgical face mask.

The company, which has been manufacturing face masks to protect against COVID-19 since July 2020, said it will begin increasing production capacity immediately, including masks for healthcare workers.

As the Delta variant becomes more widespread, “it's important for those in the healthcare and public sectors to wear quality, tested masks,” a company spokesperson said.