510(k) Summary Latex Examination Gloves Powder Free 1.0 ...
Device Name: Latex Patient Examination gloves Device Classification Name: Patient Examination gloves (21 CFR 880.6250) Device Class: Class I Product Code: Latex -LYY 3.0 Identification of The Legally Marketed Device: Class I patient Examination gloves, Powder Free, LYY which meets all the requirement of ASTM D 3578-05 and FDA 21 CFR 880.6250 ...