FDA 510(k) Applications Submitted by Khon Pu Foo

FDA 510(k) Number Submission Date Device Name Applicant
K133699 12/03/2013 POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES PT. SMART GLOVE INDONESIA
K200915 04/06/2020 Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs GX Corporation Sdn Bhd
K181047 04/19/2018 Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn.Bhd.
K171743 06/12/2017 Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves Smart Glove Corporation Sdn.Bhd
K183280 11/23/2018 PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs Smart Glove Corporation Sdn. Bhd.
K183354 12/03/2018 Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate GX Corporation SDN BHD


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