HARTALEGA NGC SDN. BHD. (LOT 39496)

FDA Device Registration & Listing · Sepang Selangor, MY · Registration 3019769825

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019769825
FEI Number
3019769825
Entity Name
HARTALEGA NGC SDN. BHD. (LOT 39496)
City/State/Country
Sepang Selangor, MY
Establishment Address
No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,, Sepang Selangor 43900, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hartalega NGC Sdn. Bhd. (Lot 39496) (Owner Number: 10090827)
Owner / Operator Contact Address
No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,, Sepang, MY-10 43900, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200019
PMA Number
N/A

All Registered 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 POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES 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 NitrilePowderFreeExaminationGlove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) 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 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) 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)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
OPC Powder-Free Polychloroprene Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-11
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-20
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-12
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-01-12
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-01-12
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-10-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-30
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-05-20
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-05-20
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-07-21
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-11
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-07-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-21

Official Correspondent

Eu Jin Kuan

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

Hartalega NGC Sdn. Bhd. (Lot 39496)
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K002933 Maxxim Medical STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES 2000-10-19
K913402 Smith & Nephew Perry PERRY(R) DERMAGUARD(R) PLUS GLOVES 1991-10-02
K894452 Kerala Rubber & Reclaims, Ltd. KRR GLOVE, PATIENT EXAMINATION GLOVES 1989-08-09
K891323 Li Wah-Hong Kong, Inc. LI WAH LATEX EXAMINATION GLOVES 1989-08-31
K891418 C & K Mfg. & Sales Co. LATEX EXAMINATION GLOVES, STYLE 510 LX 1989-06-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019769825. Last updated year: 2026. Please use registration number 3019769825 when referencing this establishment in official correspondence.
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