Medical Device Manufacturer · MY , Bandar Sri Damansara

Hartalega NGC Sdn. Bhd. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 2014
28
Total
28
Cleared
0
Denied

Hartalega NGC Sdn. Bhd. has 28 FDA 510(k) cleared general hospital devices. Based in Bandar Sri Damansara, MY.

Latest FDA clearance: Oct 2025. 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.

FDA 510(k) cleared devices by Hartalega NGC Sdn. Bhd.

28 devices
1-12 of 28
Cleared Oct 23, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs,...
K250861 · LZA
General Hospital · 216d
Cleared Jul 30, 2025
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K251319 · LZA
General Hospital · 92d
Cleared Jan 08, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K243818 · LZA
General Hospital · 27d
Cleared May 17, 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with...
K223437 · LZA
General Hospital · 184d
Cleared Nov 11, 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K222225 · LZA
General Hospital · 109d
Cleared Sep 24, 2022
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy...
K221718 · KGO
General Hospital · 103d
Cleared May 26, 2022
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K214074 · KGO
General Hospital · 150d
Cleared Aug 03, 2021
Polychloroprene Powder Free Examination Glove Tested for Use with...
K211758 · OPC
General Hospital · 57d
Cleared Aug 25, 2020
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim...
K201772 · LZA
General Hospital · 57d
Cleared Aug 05, 2020
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K201530 · LZA
General Hospital · 58d
Cleared Apr 25, 2020
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K200581 · LZA
General Hospital · 51d
Cleared Apr 06, 2020
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs...
K200019 · LZA
General Hospital · 94d
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