Hartalega NGC Sdn. Bhd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Known Names

hartalega ngc sdn bhd, hartalega ngc sdn. bhd

Recent 510(k) Clearances

K-NumberDeviceDate
K250861Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, SimuOctober 23, 2025
K251319Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CiJuly 30, 2025
K243818Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (BJanuary 8, 2025
K223437Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and FentaMay 17, 2023
K222225Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)November 11, 2022
K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)September 24, 2022
K214074Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of GloMay 26, 2022
K211758Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)August 3, 2021
K201772Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with CAugust 25, 2020
K201530Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (August 5, 2020
K200581Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and FentApril 25, 2020
K200019Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate April 6, 2020
K192232Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)November 8, 2019
K190454Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (September 26, 2019
K183536Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloAugust 16, 2019
K183389Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical UndergloveJune 28, 2019
K172442Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with ChNovember 6, 2017
K170794Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)June 30, 2017
K162646Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)March 3, 2017
K162923NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POFebruary 6, 2017