510(k) K210705

Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 by Defender Safety, Inc. — Product Code FXX

K210705 is an FDA 510(k) premarket notification submitted by Defender Safety, Inc. for the device "Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3". The FDA issued a decision of Substantially Equivalent on May 6, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Defender Safety, Inc. has 1 other 510(k) clearance on record.