Hartalega NGC Sdn Bhd
Sepang Selangor, MY
HARTALEGA NGC SDN BHD appears in FDA device records in Sepang Selangor, MY. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 31 510(k) clearances for Hartalega NGC Sdn Bhd between 2014 and 2026. The busiest year on record is 2015, with 5. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 2 |
| 2015 | 5 |
| 2016 | 1 |
| 2017 | 4 |
| 2019 | 4 |
| 2020 | 4 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| 2025 | 3 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | KGO | Substantially Equivalent | |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue | LZA | Substantially Equivalent | |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | LZA | Substantially Equivalent | |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | LZA | Substantially Equivalent | |
| K251319 | 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 | LZA | Substantially Equivalent | |
| K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | |
| K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | LZA | Substantially Equivalent | |
| K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | |
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) | KGO | Substantially Equivalent | |
| K214074 | 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 | KGO | Substantially Equivalent | |
| K211758 | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) | OPC | Substantially Equivalent | |
| K201772 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | |
| K201530 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) | LZA | Substantially Equivalent | |
| K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | |
| K200019 | 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) | LZA | Substantially Equivalent | |
| K192232 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) | LZA | Substantially Equivalent | |
| K190454 | 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 | LZA | Substantially Equivalent | |
| K183536 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | KGO | Substantially Equivalent | |
| K183389 | Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove | KGO | Substantially Equivalent | |
| K172442 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | |
| K170794 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) | LZA | Substantially Equivalent | |
| K162646 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | LZA | Substantially Equivalent | |
| K162923 | 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 | LZA | Substantially Equivalent | |
| K151997 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) | LZA | Substantially Equivalent | |
| K151836 | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK | LZA | Substantially Equivalent | |
| K151684 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) | LZA | Substantially Equivalent | |
| K151343 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) | LZA | Substantially Equivalent | |
| K150110 | 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) | LZA | Substantially Equivalent | |
| K143419 | Patient Examination Gloves | LYY | Substantially Equivalent | |
| K140890 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) | LZA | Substantially Equivalent | |
| K140610 | NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) | LZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011200663 | 3011200663 | HARTALEGA NGC SDN BHD | No. 1, Persiaran Tanjung, Sepang Selangor 43900 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QDOFentanyl And Other Opioid Protection Glove
- LYYLatex Patient Examination Glove
- LZCMedical Glove, Specialty
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- LZAPolymer Patient Examination Glove
- OPCPowder-Free Polychloroprene Patient Examination Glove
- KGOSurgeon'S Gloves
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain