510(k) K974442

PRE-POWDERED NITRILE EXAMINATION GLOVES by P.T. Latexindo Tobaperkasa — Product Code LZY

K974442 is an FDA 510(k) premarket notification submitted by P.T. Latexindo Tobaperkasa for the device "PRE-POWDERED NITRILE EXAMINATION GLOVES". The FDA issued a decision of Substantially Equivalent on January 5, 1998. The device falls under product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball), a Class II device regulated under 21 CFR 888.3360. P.T. Latexindo Tobaperkasa has at least 2 other 510(k) clearances on record.