Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

About This 510(k) Submission

K151750 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Kossan International Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on August 3, 2016, 401 days after receiving the submission on June 29, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.