510(k) K212109

Spin Care Disposable Protective Mask Level 3 by Spintech, LLC — Product Code FXX

K212109 is an FDA 510(k) premarket notification submitted by Spintech, LLC for the device "Spin Care Disposable Protective Mask Level 3". The FDA issued a decision of Substantially Equivalent on November 14, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Spintech, LLC has at least 10 other 510(k) clearances on record.