510(k) K001892

WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) by White Knight Healthcare, Inc. — Product Code FXX

K001892 is an FDA 510(k) premarket notification submitted by White Knight Healthcare, Inc. for the device "WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)". The FDA issued a decision of Substantially Equivalent on April 3, 2001. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. White Knight Healthcare, Inc. has at least 7 other 510(k) clearances on record.