510(k) K210860

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 by Gri-Alleset, Inc. — Product Code FXX

K210860 is an FDA 510(k) premarket notification submitted by Gri-Alleset, Inc. for the device "Comfort Guard Mask, level 1, Comfort Guard Mask, level 3". The FDA issued a decision of Substantially Equivalent on April 7, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Gri-Alleset, Inc. has at least 3 other 510(k) clearances on record.