510(k) K211399

Sterile Level 3 Surgical Gown by Barco Tekstil Sanayi VE Ticaret A.S. — Product Code FYA

K211399 is an FDA 510(k) premarket notification submitted by Barco Tekstil Sanayi VE Ticaret A.S. for the device "Sterile Level 3 Surgical Gown". The FDA issued a decision of Substantially Equivalent on Jul 22, 2022. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.