HARTALEGA NGC SDN BHD

FDA Device Registration & Listing · Sepang Selangor, MY · Registration 3011200663

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
3011200663
FEI Number
3011200663
Entity Name
HARTALEGA NGC SDN BHD
City/State/Country
Sepang Selangor, MY
Establishment Address
No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung, Sepang Selangor 43900, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HARTALEGA NGC SDN BHD (Owner Number: 10047371)
Owner / Operator Contact Address
No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung, Sepang, MY-10 43900, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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) Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) 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)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-07-19
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-07-19
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-07-19
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-05-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-08-27
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-08-26
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2021-08-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-06-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-06-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-05-19
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-01-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-11-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-11-15
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-08-05
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-08-05
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-08-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-08-05
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-11-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-11-15
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2020-08-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-08-06
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-08-06
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2018-11-12
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-08-03
OPC Powder-Free Polychloroprene Patient Examination Glove General Hospital Class 1 880.6250 2021-08-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-05-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-05-18
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-05-18
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-05-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-03-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-07-12
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-07-12
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-07-12
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-07-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-04-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-10-19
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-10-19
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-04-04
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2015-03-08
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2016-06-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-06-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-04-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-04-28
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2020-04-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-11-10
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-07-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-07-18
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-07-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-11-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-11-17
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2018-11-15
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-05-30
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-05-30
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2022-11-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2019-06-30
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2015-09-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-09-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-12-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2021-12-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-08-25
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2020-08-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-08-25
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 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
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-08-18
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2019-08-19
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-05-17
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2021-05-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-08-27
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-08-27
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-12-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-12-12
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-05-19
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-08-27
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-03-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-03-15
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-11-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-11-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-11-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-06-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-06-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-11-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-11-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-07-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-03-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-10-19
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-10-19
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-25
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-24

Official Correspondent

KUAN MUN LEONG

US Agent Details

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

Related Public Records

Same Entity

HARTALEGA NGC SDN BHD
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
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21
K101595 Better Care Plastic Technology Cp., Ltd. POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE 2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011200663. Last updated year: 2026. Please use registration number 3011200663 when referencing this establishment in official correspondence.
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