510(k) K181315

Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing by Winner Medical Co., Ltd. — Product Code FRO

K181315 is an FDA 510(k) premarket notification submitted by Winner Medical Co., Ltd. for the device "Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing". The FDA issued a decision of Substantially Equivalent on February 14, 2019. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Winner Medical Co., Ltd. has at least 10 other 510(k) clearances on record.