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

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

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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