510(k) K963458

PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS by Skil-Care Corp. — Product Code FMQ

K963458 is an FDA 510(k) premarket notification submitted by Skil-Care Corp. for the device "PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS". The FDA issued a decision of Substantially Equivalent on October 18, 1996. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Skil-Care Corp. has at least 10 other 510(k) clearances on record.