Hartalega NGC Sdn. Bhd. is one of 169 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Hartalega NGC Sdn. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue, Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC Sdn. Bhd. has 31 FDA 510(k) cleared general hospital devices. Based in Bandar Sri Damansara, MY.
Latest FDA clearance: Jul 2026. Active since 2014.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hartalega Sdn Bhd as regulatory consultant.