FDA Registration
Active
🇲🇾 Malaysia
HARTALEGA NGC SDN BHD
Reg #: 3011200663
·
FEI: 3011200663
·
Expires 2026
Products
7
Proprietary Names
62
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- HARTALEGA NGC SDN BHD
- Registration Number
- 3011200663
- FEI Number
- 3011200663
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
- City
- Sepang Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K201748
Owner / Operator
- Firm Name
- HARTALEGA NGC SDN BHD
- Operator Number
- 10047371
- Address
- No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
- City
- Sepang
- State
- Selangor
- Postal Code
- 43900
- Country
- MY
- Correspondent
- KUAN MUN LEONG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-07-19 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-07-19 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2022-07-19 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2021-08-26 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2017-05-19 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-08-05 |
| Powder-Free Polychloroprene Patient Examination Glove | OPC | Class 1 | General Hospital | No | 2021-08-03 |
Proprietary Names
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
Chlorinated PF Latex Exam Glove with Protein Labeling Claim 50ug or less
Pro advantage Latex Powder Free
Labsco Latex Powder Free
Quala Latex Powder Free
Nitrile Powder Free Exmiantion Gloves - Orange
Nitrile Powder Free Examintion Gloves - Pink
Nitrile Powder Free Examination Gloves - Black
Nitrile Powder Free Examination Gloves - Green
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
Sterile Nitrile PF Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
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 - White
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)
Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant with Protein Labeling Claim of 50 Microgr
Blue Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - CBLU
Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - ABLU
Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - VBLU
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
Nitrile Powder Free Exam Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Evolution One
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
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
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
Polyisoprene Powder Free Surgical for Use with Chemotherapy Drugs (Natural)
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue)
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
and Fentanyl Citrate (Blue)
Nitrile Powder Free Examination Gloves
SAMA NB 32 VBLU
SOLM 3G VIOLET BLUE NITRILE PF EXAM GLOVE
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
Latex PD Exam Glove with Protein Labeling claim of 200ug or less per gram
Nitrile Powder Free Examination Glove - Dark Violet Blue (DVBU)
Nitrile Powder Free Examination Glove - Cobalt Blue (CBLU)
Nitrile Powder Free Examination Glove - White
Nitrile Powder Free Examination Glove - Dawn Blue
Nitrile PF Exam Glove Tested for Use with Chemo Drugs ABLU,VBLU,DKBU,DVBU
Sante Premium Blue Nitrile Examination Gloves
KINGSEAL NITRILE GLOVES
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
Biodegradable Nitrile Powder Free Examination Glove (Blue)
STERLE NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
STERILE NITRILE POWDER FREE EXAMINATION GLOVE (VBLU)
Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (Blue)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
Nitrile PF Exam Glove with Colloidal Oatmeal USP with LDP Claim and Tested For Use with Chemotherapy Drugs (White)
Nitrile Cornflower Blue Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs
Powderfree Nitrile Patient Examination Gloves
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue)
CRITERION N300 BLACK
Sterile Nitrile PF Examination Glove Tested for Use with Chemotherapy Drugs (ABLU) and (VBLU) - Extended Cuff
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device