Smart Glove Corporation Sdn. Bhd. is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Smart Glove Corporation Sdn. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs, Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
5
Total
5
Cleared
0
Denied
Smart Glove Corporation Sdn. Bhd. has 5 FDA 510(k) cleared medical devices. Based in Klang, MY.
Last cleared in 2022. Active since 2017. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Smart Glove Corporation Sdn. Bhd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Smart Glove Corporation Sdn. Bhd.
5 devices
Cleared
Mar 10, 2022
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with...
General Hospital
149d
Cleared
Jul 26, 2019
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested...
General Hospital
245d
Cleared
Jan 09, 2019
Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested...
General Hospital
265d
Cleared
Aug 08, 2018
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical...
General Hospital
195d
Cleared
Nov 17, 2017
Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free...
General Hospital
158d