Medical Device Manufacturer · MY , Bandar Sri Damansara

Hartalega NGC Sdn. Bhd.

28 submissions · 28 cleared · Since 2014
28
Total
28
Cleared
0
Denied

Hartalega NGC Sdn. Bhd. — FDA 510(k) Submissions

Hartalega NGC Sdn. Bhd. has submitted 28 FDA 510(k) premarket notifications since 2014, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Polymer Patient Examination Glove, Surgeon's Gloves, Latex Patient Examination Glove, Powder-free Polychloroprene Patient Examination Glove . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
K250861 · LZA Polymer Patient... · General Hospital
Oct 2025 216d
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 Cuff
K251319 · LZA Polymer Patient... · General Hospital
Jul 2025 92d
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K243818 · LZA Polymer Patient... · General Hospital
Jan 2025 27d
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
K223437 · LZA Polymer Patient... · General Hospital
May 2023 184d
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
K222225 · LZA Polymer Patient... · General Hospital
Nov 2022 109d
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
K221718 · KGO Surgeon's Gloves · General Hospital
Sep 2022 103d
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
K214074 · KGO Surgeon's Gloves · General Hospital
May 2022 150d
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
K211758 · OPC Powder-free... · General Hospital
Aug 2021 57d
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K201772 · LZA Polymer Patient... · General Hospital
Aug 2020 57d
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
K201530 · LZA Polymer Patient... · General Hospital
Aug 2020 58d
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K200581 · LZA Polymer Patient... · General Hospital
Apr 2020 51d
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
K200019 · LZA Polymer Patient... · General Hospital
Apr 2020 94d
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
K192232 · LZA Polymer Patient... · General Hospital
Nov 2019 84d
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 Cuff
K190454 · LZA Polymer Patient... · General Hospital
Sep 2019 213d
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K183536 · KGO Surgeon's Gloves · General Hospital
Aug 2019 240d
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
K183389 · KGO Surgeon's Gloves · General Hospital
Jun 2019 204d
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K172442 · LZA Polymer Patient... · General Hospital
Nov 2017 87d
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
K170794 · LZA Polymer Patient... · General Hospital
Jun 2017 106d
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162646 · LZA Polymer Patient... · General Hospital
Mar 2017 162d
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE
K162923 · LZA Polymer Patient... · General Hospital
Feb 2017 111d
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
K151997 · LZA Polymer Patient... · General Hospital
Mar 2016 255d
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
K151836 · LZA Polymer Patient... · General Hospital
Oct 2015 107d
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
K151684 · LZA Polymer Patient... · General Hospital
Sep 2015 88d
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
K151343 · LZA Polymer Patient... · General Hospital
Aug 2015 97d
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
K150110 · LZA Polymer Patient... · General Hospital
Apr 2015 93d
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