510(k) K953754

GLOBAL HEALTHCARE FACE MASK by Global Healthcare, Inc. — Product Code FXX

K953754 is an FDA 510(k) premarket notification submitted by Global Healthcare, Inc. for the device "GLOBAL HEALTHCARE FACE MASK". The FDA issued a decision of Substantially Equivalent on January 26, 1996. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Global Healthcare, Inc. has at least 2 other 510(k) clearances on record.