510(k) K925628

ULTRATUFF CUT RESISTANT GLOVE LINER by Baxter Healthcare Corp — Product Code LYU

K925628 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ULTRATUFF CUT RESISTANT GLOVE LINER". The FDA issued a decision of Substantially Equivalent on Jul 9, 1993. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Baxter Healthcare Corp has 507 other 510(k) clearances on record.