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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
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