FDA 510(k) Applications Submitted by CHAN YEW MEN

FDA 510(k) Number	Submission Date	Device Name	Applicant
K190080	01/16/2019	Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)	Comfort Rubber Gloves Industries Sdn. Bhd.
K180476	02/22/2018	Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs	Comfort Rubber Gloves Industries Sdn. Bhd.
K171541	05/26/2017	Powder Free Nitrile Examination Gloves (Orange)	Comfort Rubber Gloves Industries Sdn. Bhd.
K162405	08/29/2016	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)	COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
K110701	03/14/2011	ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500	DNA GENOTEK INC