Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

About This 510(k) Submission

K151824 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, 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 2, 2016, 393 days after receiving the submission on July 6, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.