510(k) K211066

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 by Homtex, Inc. — Product Code FXX

K211066 is an FDA 510(k) premarket notification submitted by Homtex, Inc. for the device "Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3". The FDA issued a decision of Substantially Equivalent on Aug 19, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Homtex, Inc. has 1 other 510(k) clearance on record.