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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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