Data / Medical devices / Malaysia / Hartalega NGC Sdn Bhd

Hartalega NGC Sdn Bhd: FDA-registered device maker in Sepang Selangor, Malaysia, 49 510(k) clearances

Hartalega NGC Sdn Bhd is registered with the FDA (registration 3011200663) in Sepang Selangor, Malaysia. It lists 7 device types. The FDA files 49 510(k) clearances under its listings, the newest dated July 28, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3011200663

Address

No. 1, Persiaran Tanjung Kawasan Perindustrian Tanjung, Sepang Selangor, Malaysia, 43900

Owner or operator

HARTALEGA NGC SDN BHD (10047371)

Roles

Contract manufacturer, Manufacturer

First device listed

August 18, 2014

Registered through

2026

Brand names listed

Biodegradable Nitrile Powder Free Examination Glove (Blue), Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour), Blue Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - CBLU, CRITERION N300 BLACK, Chlorinated PF Latex Exam Glove with Protein Labeling Claim 50ug or less, Evolution One, KINGSEAL NITRILE GLOVES, Labsco Latex Powder Free and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Compare with other makers

• All makers of Medical Glove, Specialty
• All makers of Polymer Patient Examination Glove
• All makers of Latex Patient Examination Glove
• All makers of Fentanyl And Other Opioid Protection Glove
• All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
• All makers of Powder-Free Polychloroprene Patient Examination Glove

Updated July 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.