FDA Registration
Active
🇲🇾 Malaysia
HARTALEGA NGC SDN. BHD. (LOT 39496)
Reg #: 3019769825
·
FEI: 3019769825
·
Expires 2026
Products
7
Proprietary Names
89
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- HARTALEGA NGC SDN. BHD. (LOT 39496)
- Registration Number
- 3019769825
- FEI Number
- 3019769825
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,
- City
- Sepang Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K221718
Owner / Operator
- Firm Name
- Hartalega NGC Sdn. Bhd. (Lot 39496)
- Operator Number
- 10090827
- Address
- No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,
- City
- Sepang
- State
- Selangor
- Postal Code
- 43900
- Country
- MY
- Correspondent
- Eu Jin Kuan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2025-07-21 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-07-21 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2025-07-21 |
| Powder-Free Polychloroprene Patient Examination Glove | OPC | Class 1 | General Hospital | No | 2025-07-21 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-07-21 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-07-21 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-01-12 |
Proprietary Names
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU)
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
NitrilePowderFreeExaminationGlovewithColloidalOatmealUSPSkinProtectantandTestedforUseWithChemotherapyDrug (Dawn Blue)
Patient Examination Gloves
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
NitrilePowderFreeExaminationGlove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Nitrile PF Exam Glove with Colloidal Oatmeal USP with LDP Claim and Tested For Use with Chemotherapy Drugs (White)
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (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 - Dawn Blue
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
POWDER FREE STERILE LATEX SURGICAL GLOVES
Nitrile Powder Free Examination Glove (Blue)
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Latex Polymer Coated PF Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)
Latex PolymerCoated PF Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural)
Polyisoprene Powder Free Surgical Glove
Polyisoprene Powder Free Surgical Underglove
NITRILE POWDER FREE EXAMINATION GLOVES-PINK
NITRILE POWDER FREE EXAMINATION GLOVES-GREEN
NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE
NitrilePowderFreeExaminationGloves Tested for Use with Chemotherapy Drugs (White); DarkVioletBlue (DVBU); DarkBlue (DKBU
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
LatexPFSurgicalGlovewithProteinLabellingClaim of 50Microgram or LessperGram of Glove and Tested for use with Chemo Drugs
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
POLYISOPRENE POWDER FREE SURGICAL GLOVE
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
LatexPowderFreeSurgicalGlovewithProteinLabelingClaimof50MicrogramorLessperGramofGloveandTestedforUsewithChemotherapyDrug
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
BiodegradableNitrilePowderFreeExaminationGlove TestedforUsewith Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue)
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey)
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white blue orange)
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
NitrilePFExaminationGloveswithLowDermatitisPotentialClaimandTestedforUsewithChemotherapyDrugsandFentanylCitrate(Blue)
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.
PATIENT EXAMINATION GLOVES
PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
NitrilePowderFreeExaminationGlove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Bllue)
Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs; White, Violet Blue, Aqua Blue and Violet
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE
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 VIOLET BLUE
Biodegradable Nitrile Powder Free Examination Glove (Blue)
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU)
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
POWDER FREE STERILE LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Establishment Types
Manufacture Medical Device