Hartalega NGC Sdn. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
31
Total
31
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hartalega NGC Sdn. Bhd. General Hospital ✕
31 devices
Cleared
Jul 28, 2026
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and...
General Hospital
159d
Cleared
Jul 20, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
General Hospital
201d
Cleared
Jun 17, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
General Hospital
92d
Cleared
Oct 23, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs,...
General Hospital
216d
Cleared
Jul 30, 2025
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
General Hospital
92d
Cleared
Jan 08, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
General Hospital
27d
Cleared
May 17, 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with...
General Hospital
184d
Cleared
Nov 11, 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
General Hospital
109d
Cleared
Sep 24, 2022
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy...
General Hospital
103d
Cleared
May 26, 2022
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
General Hospital
150d
Cleared
Aug 03, 2021
Polychloroprene Powder Free Examination Glove Tested for Use with...
General Hospital
57d
Cleared
Aug 25, 2020
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim...
General Hospital
57d