Hartalega NGC Sdn. Bhd

FDA Filings

This page includes the latest FDA filings for Hartalega NGC Sdn. Bhd. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Hartalega NGC Sdn. Bhd.
Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (White)2019-11-08
Hartalega Ngc Sdn. Bhd.
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) - Extended Cuff2019-09-26
Hartalega Ngc Sdn. Bhd.
Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove2019-08-16
Hartalega NGC Sdn. Bhd.
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove2019-06-28

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate

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