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
FDA 510(k) Regulatory Record - Koon Seng Sdn Bhd General Hospital ✕
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