510(k) K212926

AllureTM Surgical Mask by Allure Gift Wraps Private Limited — Product Code FXX

K212926 is an FDA 510(k) premarket notification submitted by Allure Gift Wraps Private Limited for the device "AllureTM Surgical Mask". The FDA issued a decision of Substantially Equivalent on Sep 16, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.