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TAIJI Medical Supplies, Inc. Receives FDA 510(k) Clearance on Its Surgical Mask and Increases Production as Delta Variant Cases Surge

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“Even our consumer 3-ply masks were tested earlier this year and passed the new ASTM F3502-21 standard for barrier face coverings which includes critical tests for particulate filtration and breathability.”


LINCOLNTON, N.C. (PRWEB)

TAIJI Medical Supplies, Inc. (TMS) announced today that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for its Professional Series Level 3 Surgical Face Mask. TMS will begin increasing production capacity of all face mask products immediately. This includes masks for children, adults and those working in a healthcare environment.

On July 27, 2021, the Center for Disease Control (CDC) updated their mask guidance, recommending that:

  •     vaccinated people wear masks indoors in certain areas, and;

  •     everyone in K through 12 schools wear a mask indoors, including teachers, staff, students and visitors, regardless of vaccination status

“The FDA 510(k) clearance of our surgical mask offering marks the culmination of many hours of refinement, testing and determination to offer the best US-made product,” said Dan Grayson / Vice President of Sales and Operations. “As the Delta variant becomes more widespread, it’s important for those in the healthcare and public sectors to wear quality, tested masks,” Grayson continued. “Even our consumer 3-ply masks were tested earlier this year and passed the new ASTM F3502-21 standard for barrier face coverings, which includes critical tests for particulate filtration and breathability.”

TAIJI Medical Supplies, Inc., (TMS) based in Lincolnton, NC, is a United States manufacturer of PPE, (specifically face masks) with 120,000 square feet of manufacturing space and the capacity to produce millions of face masks per month. TMS has been producing quality, US-made face masks since July 2020.

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