Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)

About This 510(k) Submission

K162405 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on March 28, 2017, 211 days after receiving the submission on August 29, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.