FDA Registration
Active
🇲🇾 Malaysia
HARTALEGA SDN BHD
Reg #: 8040614
·
FEI: 3002807146
·
Expires 2026
Products
5
Proprietary Names
71
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HARTALEGA SDN BHD
- Registration Number
- 8040614
- FEI Number
- 3002807146
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No 7, Kawasan Perusahaan Suria
- City
- Bestari Jaya Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K993722
Owner / Operator
- Firm Name
- HARTALEGA SDN BHD
- Operator Number
- 8040614
- Address
- C-G-9,Jalan Dataran SD1,Dataran SD PJU9, Bandar Sri Damansara
- City
- KUALA LUMPUR
- State
- MY-NOTA
- Postal Code
- 52200
- Country
- MY
- Correspondent
- KUAN - KAM HON
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Dr Ste 114
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2007-11-29 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2007-11-29 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2007-12-27 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2020-08-06 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2020-08-06 |
Proprietary Names
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.
Powderfree Nitrile Patient Examination
Nitrile Powder Free Examination Glove (Blue)
Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Mi
POWDERED STERILE LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
Nitrile Powder Free Examination Glove (Aqua Blue)
Nitrile Powder Free Examination Glove (Aqua Blue) - Extended Cuff
Nitrile Powder Free Examination Glove (Orange)
Nitrile Powder Free Examination Glove (Black)
Nitrile Powder Free Examination Glove (Black) - Extended Cuff
Nitrile Powder Free Examination Glove (Orange) - Extended Cuff
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (blue)
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Sterile Nitrile Powder Free Examination Gloves - Aqua Blue (ABLU)
Sterile Nitrile Powder Free Examination Gloves - Violet Blue (VBLU)
Nitrile Powder Free Examination Gloves
Powder Free Latex Patient Examination Gloves
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
Shieldfive
Chlorinated Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less)
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
POWDER FREE STERILE LATEX SURGICAL GLOVES
NITRILE POWDERED EXAMINATION GLOVES (WHITE)
Sante Premium Blue Nitrile Examination Gloves
Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - VBLU
Nitrile powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - ABLU
Blue Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs - CBLU
Biodegradable Nitrile Powder Free Examination Glove (Blue)
Nitrile PF Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
Powdered Latex Examination Glove with Protein Content Labeling Claim (200 micrograms or less)
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs -Dark Violet Blue (DVBU)
Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs -Dark Blue (DKBU)
Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (White)
Multiple
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove
Polyisoprene Powder Free Surgical Underglove, Polyisoprene Powder Free Surgical Glove
Nitrile Powder Free Eamination Gloves Tested for Use with Chemotherapy Drugs; White, Violet Blue, Aqua Blue and Violet
Nitrile Powder Free Examination Glove with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs
Patient Examination Gloves Latex
Powder - Free Latex Examination Gloves
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
NITRILE POWDERED EXAMINATION GLOVES (BLUE)
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
Nitrile PF Exam Glove with Colloidal Oatmeal USP with LDP Claim and Tested For Use with Chemotherapy Drugs (White)
POWDER FREE STERILE LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Nitrile Powder Free Examination Gloves (White)
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
Confiderm 3 14-6N3x
Nitrile Powder Free Examination Gloves (Blue)
Nitrile Powder Free Examination Gloves (Pink)
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue)
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU)
Latex PCPF Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)
Latex PCPF Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural)
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Nitrile PF Exam Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility