Koon Seng Sdn Bhd is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Koon Seng Sdn Bhd - FDA 510(k) Cleared Devices
Recent clearances: Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue), KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
7
Total
7
Cleared
0
Denied
Koon Seng Sdn Bhd has 7 FDA 510(k) cleared medical devices. Based in 81707 Pasir Gudan, Johor, MY.
Last cleared in 2021. Active since 1989. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Koon Seng Sdn Bhd Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Mdi Consultants, Inc. and Truscott Medsci Associates, LLC.
FDA 510(k) Regulatory Record - Koon Seng Sdn Bhd
7 devices
Cleared
Dec 21, 2021
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with...
General Hospital
125d
Cleared
Feb 22, 2018
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for...
General Hospital
307d
Cleared
Jul 14, 2011
ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
General Hospital
100d
Cleared
Dec 02, 2009
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN...
General Hospital
34d
Cleared
Dec 07, 2001
ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
General Hospital
45d
Cleared
Oct 31, 2001
ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH...
General Hospital
78d
Cleared
May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
General Hospital
68d