510(k) K133070

SURGICAL FACE MASK (Ear Loops and Tie-on) by Bh Medical Products Co., Ltd. — Product Code FXX

K133070 is an FDA 510(k) premarket notification submitted by Bh Medical Products Co., Ltd. for the device "SURGICAL FACE MASK (Ear Loops and Tie-on)". The FDA issued a decision of Substantially Equivalent on June 22, 2015. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Bh Medical Products Co., Ltd. has at least 2 other 510(k) clearances on record.