Blackbriar Regulatory Services’ Surgical Masks Gain 510(k) Clearance

Richmond, Va.-based Blackbriar Regulatory Services (BRS) has received 510(k) clearance from the FDA for its surgical three- and four-ply masks.

BRS makes three-ply and four-ply surgical masks that have gone through third-party biocompatibility testing and meet the standards of the American Society for Testing and Materials.

BRS, which offers regulatory, analytical and contract manufacturing services to other devicemakers, has expanded its Richmond facility to include a 15,000 square-foot manufacturing space dedicated entirely to the production of face masks.