Company · MY
Hartalega NGC Sdn. Bhd.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2026 | K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgica Hartalega NGC Sdn. Bhd., MY | KGO |
| Jul 20, 2026 | K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examinati Hartalega NGC Sdn. Bhd., MY | LZA |
| Jun 17, 2026 | K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powde Hartalega NGC Sdn. Bhd., MY | LZA |
| Oct 23, 2025 | K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid a Hartalega NGC Sdn. Bhd., MY | LZA |
| Jul 30, 2025 | K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Steril Hartalega NGC Sdn. Bhd., MY | LZA |
| Jan 8, 2025 | K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega NGC Sdn. Bhd., MY | LZA |
| May 17, 2023 | K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Hartalega NGC Sdn. Bhd., MY | LZA |
| Nov 11, 2022 | K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) Hartalega NGC Sdn. Bhd., MY | LZA |
| Sep 24, 2022 | K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) Hartalega NGC Sdn. Bhd., MY | KGO |
| May 26, 2022 | K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Us Hartalega NGC Sdn. Bhd., MY | KGO |
| Aug 3, 2021 | K211758 | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) Hartalega NGC Sdn. Bhd., MY | OPC |
| Aug 25, 2020 | K201772 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs an Hartalega NGC Sdn. Bhd., MY | LZA |
| Aug 5, 2020 | K201530 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) Hartalega NGC Sdn. Bhd., MY | LZA |
| Apr 25, 2020 | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega NGC Sdn. Bhd., MY | LZA |
| Apr 6, 2020 | K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powd Hartalega NGC Sdn. Bhd., MY | LZA |
| Nov 8, 2019 | K192232 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) Hartalega NGC Sdn. Bhd., MY | LZA |
| Sep 26, 2019 | K190454 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powde Hartalega NGC Sdn. Bhd., MY | LZA |
| Aug 16, 2019 | K183536 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove Hartalega NGC Sdn. Bhd., MY | KGO |
| Jun 28, 2019 | K183389 | Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove Hartalega NGC Sdn. Bhd., MY | KGO |
| Nov 6, 2017 | K172442 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Bl Hartalega NGC Sdn. Bhd., MY | LZA |
| Jun 30, 2017 | K170794 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) Hartalega NGC Sdn. Bhd., MY | LZA |
| Mar 3, 2017 | K162646 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) Hartalega NGC Sdn. Bhd., MY | LZA |
| Feb 6, 2017 | K162923 | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATIO Hartalega NGC Sdn. Bhd., MY | LZA |
| Mar 31, 2016 | K151997 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) Hartalega NGC Sdn. Bhd., MY | LZA |
| Oct 21, 2015 | K151836 | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATIO Hartalega NGC Sdn. Bhd., MY | LZA |
| Sep 18, 2015 | K151684 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) Hartalega NGC Sdn. Bhd., MY | LZA |
| Aug 24, 2015 | K151343 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) Hartalega NGC Sdn. Bhd., MY | LZA |
| Apr 23, 2015 | K150110 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examinatio Hartalega NGC Sdn. Bhd., MY | LZA |
| Mar 6, 2015 | K143419 | Patient Examination Gloves Hartalega NGC Sdn. Bhd., MY | LYY |
| Jul 24, 2014 | K140890 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) Hartalega NGC Sdn. Bhd., MY | LZA |
| Jun 20, 2014 | K140610 | NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) Hartalega NGC Sdn. Bhd., MY | LZA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||