Hartalega Snd. Bhd. is one of 219 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Hartalega Snd. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs, NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
2
Total
2
Cleared
0
Denied
Hartalega Snd. Bhd. has 2 FDA 510(k) cleared medical devices. Based in Bestari Jaya, MY.
Historical record: 2 cleared submissions from 2012 to 2016. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Hartalega Snd. Bhd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Hartalega Snd. Bhd.
2 devices