510(k) K110455

KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS by Kimberly-Clark Corp. — Product Code FXX

K110455 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS". The FDA issued a decision of Substantially Equivalent on April 29, 2011. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.