Top Calibre Sdn Bhd - FDA 510(k) Cleared Devices
Recent clearances: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS, MULTIPLE NAME, LATEX EXAMINATION GLOVES (POWDER FREE)
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Top Calibre Sdn Bhd General Hospital ✕
5 devices
Cleared
Apr 08, 2014
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE...
General Hospital
106d
Cleared
Mar 05, 2013
MULTIPLE NAME
General Hospital
83d
Cleared
May 14, 2012
LATEX EXAMINATION GLOVES (POWDER FREE)
General Hospital
68d
Cleared
May 08, 2012
LATEX EXAMINATION GLOVES (POWDERED)
General Hospital
62d
Cleared
Jan 18, 2012
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
General Hospital
133d