RB Sigma has received NIOSH approval for its N95 Filtering Facepiece Respirator.

RB Sigma announced that its domestically manufactured N95 Filtering Facepiece Respirator was approved by the National Institute for Occupational Safety and Health (NIOSH).

Approval by NISOH means the mask meets the requirements of Title 42, Code of Federal Regulations, Part 84 (42 CFR 84).

“This is a tremendous accomplishment for our team and was the culmination of thousands of hours of research, testing, and designing of our quality management system,” said Justin Bloyd, president of RB Sigma. “This achievement could not have been done without the dedication of every employee at our company. There are very few domestic manufacturers of NIOSH Approved respirators, and RB Sigma is very proud to be included amongst them.”

In April 2020, RB Sigma was instrumental in delivering PPE to the U.S. to alleviate supply shortages at the time.

Recognizing that the United States was seriously deficient in the manufacturing of masks and other filtering facepiece respirators, RB Sigma established a manufacturing facility in July of that year to make 15 million masks per month.

Through the Retooling and Reshoring Grant, RB Sigma was awarded a $500,000 grant to aid in bringing automation to the manufacturing of masks. The company quickly started designing and building machines to manufacture facemasks.

RB Sigma produces its PPE in Mentor, Ohio, with two facilities totaling 50,000 square feet in size. The company is adding durable medical equipment and home medical equipment to its medical products portfolio.

Photo courtesy of RB Sigma