Sign in Sign up

← Every applicant

Hartalega NGC Sdn. Bhd. FDA Approvals

0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate510(k)Jul 28, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 28, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue510(k)Jul 20, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Jul 20, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)510(k)Jun 17, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Jun 17, 2026
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)510(k)Oct 23, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 23, 2025
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff510(k)Jul 30, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 30, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)510(k)Jan 8, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Jan 8, 2025
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)510(k)May 17, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 17, 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)510(k)Nov 11, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Nov 11, 2022
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)510(k)Sep 24, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 24, 2022
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs510(k)May 26, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 26, 2022
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)510(k)Aug 3, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 3, 2021

Related datasets

FDA RecallsWhat the FDA has made companies pull, and how serious.Workplace SafetyOSHA inspections and citations, by company.Congress TradingThe live feed of disclosed transactions.Politician SearchEvery member who files, and what they hold.