510(k) K142990

Insta-Gard Surgical and Procedure Face Mask by Cardinal Health200, LLC — Product Code FXX

K142990 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "Insta-Gard Surgical and Procedure Face Mask". The FDA issued a decision of Substantially Equivalent on March 4, 2015. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Cardinal Health200, LLC has at least 10 other 510(k) clearances on record.