Hartalega Ngc Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Hartalega Ngc Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011200663
FEI Number3011200663
NameMANOJ ZACHARIAS
Owner & OperatorHARTALEGA NGC SDN BHD
Contact AddressNo. 1, Persiaran Tanjung Kawasan Perindustrian Tanjung
Sepang MY-10 Selangor 43900 MY
US Agent
Importing Logistics Registration
ImporterAdenna Ontario
AddressCA
Ontario, CA 91761 UNITED STATES
Importing Logistics Registration
ImporterAnsell
Address300 Industry Drive, Pittsburgh, PA, 15275
Pittsburgh, PA 15275 UNITED STATES
Importing Logistics Registration
ImporterAscend Eagle
AddressCranberry USA Inc. Pinhole, California 94564 USA
Pinole, CA 94564 UNITED STATES
Importing Logistics Registration
ImporterBellissimo Foods
AddressHouston, TX,
Astrodome, TX 77025 UNITED STATES
Importing Logistics Registration
ImporterDiamond Gloves
AddressIrvine, CA
Irvine, CA 92602 UNITED STATES
Importing Logistics Registration
ImporterEcobee Inc.
AddressPinole
Pinole, CA 94564 UNITED STATES
Importing Logistics Registration
ImporterHBM Group, Inc.
AddressHBM Group, Inc. New York 11788, USA
Hauppauge, NY 11788 UNITED STATES
Importing Logistics Registration
ImporterHenry Schein Inc
Address135 Duryea Road, Melville, NY 11747 USA
Dix Hills, NY 11747 UNITED STATES
Importing Logistics Registration
ImporterMcKesson Medical
AddressMckesson Medical-Surgical Inc, Richmond, VA 23228
Henrico, VA 23228 UNITED STATES
Importing Logistics Registration
ImporterPL Sourcing, Inc
AddressP.0 Box 2778 Newport News, VA
Newport News, VA 23602 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address75 EXECUTIVE DR, STE 114
Aurora, IL 60504 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
HARTALEGA NGC SDN. BHD.
 PROFENCE BLUE BIODEGRADABLE 2023-08-31
HARTALEGA NGC SDN. BHD.
 PROFENCE BLUE BIODEGRADABLE 2023-08-31
HARTALEGA NGC SDN. BHD.
 PROFENCE BLUE BIODEGRADABLE 2023-08-31
HARTALEGA NGC SDN. BHD.
 PROFENCE BLUE BIODEGRADABLE 2023-08-31
HARTALEGA NGC SDN. BHD.
 PROFENCE BLUE BIODEGRADABLE 2023-08-31
Hartalega NGC SDN BHD
Polyisoprene Powder Free Surgical Glove Tested For Use With Chemotherapy Drugs (Natural)2022-09-24
Hartalega NGC SDN. BHD.
Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs2022-05-26
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
HARTALEGA NGC SDN. BHD.
 PROFENCE Nitrile Powder Free Examination Gloves 2022-04-12
Hartalega Ngc Sdn. Bhd.
Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Fusion Dark Grey)2020-08-05
Hartalega NGC SDN. BHD.
Biodegradable Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)2020-04-25
Hartalega NGC Sdn. Bhd.
Nitrile Powder Free Examination Gloved Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Black)2020-04-06
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)2019-11-10
Hartalega NGC Sdn. Bhd.
Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (White)2019-11-08
Hartalega Ngc Sdn. Bhd.
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 Cuff2019-09-26
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram2019-08-19
Hartalega Ngc Sdn. Bhd.
Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove2019-08-16
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove2019-06-30
Hartalega NGC Sdn. Bhd.
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove2019-06-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Evolution One2018-11-15
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)2018-05-25
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)2018-05-25
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Exam Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)2017-11-17
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Exam Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)2017-11-17
Hartalega NGC SDN. BHD.
Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs (Blue)2017-11-06
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Powderfree Nitrile Patient Examination Gloves2017-10-27
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)2017-09-27
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Sterile Nitrile PF Exam Glove, Violet Blue (VBLU)2017-07-07
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Sterile Nitrile PF Exam Glove, Aqua Blue (ABLU)2017-07-07
HARTALEGA NGC SDN. BHD.
Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (White)2017-06-30
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Quala Latex Powder Free2017-05-19
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Pro advantage Latex Powder Free2017-05-19
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Labsco Latex Powder Free2017-05-19
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Chlorinated PF Latex Exam Glove with Protein Labeling Claim 50ug or less2017-05-19
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Latex PD Exam Glove with Protein Labeling claim of 200ug or less per gram2017-05-19
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs ? Violet Blue2017-03-15
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs ? Dark Violet Blue2017-03-15
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs ? Dark Blue2017-03-15
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs ? Aqua Blue2017-03-15
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs ? Violet Blue2017-03-15
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs ? Dark Violet Blue2017-03-15
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs ? Dark Blue2017-03-15
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs ? Aqua Blue2017-03-15
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (Blue)2017-03-15
HARTALEGA NGC SDN. BHD.
Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (Blue)2017-03-03
HARTALEGA NGC SDN. BHD.
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 CHEMOTHERA2017-02-06
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Cornflower Blue Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs2016-07-12
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - VBLU2016-06-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - ABLU2016-06-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Blue Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - CBLU2016-06-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - VBLU2016-06-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - ABLU2016-06-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Blue Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - CBLU2016-06-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)2016-04-04
HARTALEGA NGC SDN BHD
Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs-Violet Blue (VBLU)2016-03-31
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Exmiantion Gloves - Orange2016-01-18
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examintion Gloves - Pink2016-01-18
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Gloves - Green2016-01-18
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Gloves - Black2016-01-18
HARTALEGA NGC SDN BHD
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK2015-10-21
HARTALEGA NGC SDN. BHD.
Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim(Blue)2015-09-18
HARTALEGA NGC SDN BHD
Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (white, Blue, Orange)2015-08-24
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White2015-04-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue2015-04-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)2015-04-28
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU)2015-04-28
HARTALEGA NGC SDN. BHD.
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 S2015-04-23
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant with Protein Labeling Claim of 50 Microgr2015-03-08
HARTALEGA NGC SDN. BHD.
Patient Examination Gloves2015-03-06
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove - White2014-08-27
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove - Dawn Blue2014-08-27
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove - Dark Violet Blue (DVBU)2014-08-27
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Glove - Cobalt Blue (CBLU)2014-08-27
MANOJ ZACHARIAS [HARTALEGA NGC SDN BHD]
Nitrile Powder Free Examination Gloves2014-08-18
HARTALEGA NGC SDN. BHD.
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)2014-07-24
HARTALEGA NGC SDN. BHD.
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)2014-06-20

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009269482Singapore,Singapore -> New York/Newark Area, Newark, New JerseyGLOVES2282 CAS
2020092619729Port Swettenham,Malaysia -> Savannah, GeorgiaNITRILE EXAMINATION GLOVES2238 CAS
2020092427714Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyGLOVES 17940.080 KGS 58 CBM SHIPPER LOAD, COUNT AND SEALED 1 X 40'HC 2282 CASES FOB PORT KLANG, MALAYSIA 2282 CASES2282 CAS
2020092423704Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey240 CTN 240 QTY 781.390 2.740PO NO.: 1054829G LOVE, NITRILE PF, S, (HTS# 4015191010)SKU NO. 4882671,480 CTN 1,480 QTY 5,173.780 16.920PO NO.: 1054829GLOVE, NITRILE PF, M, (HTS# 4015 191010)SKU NO. 4882781,810 CTN 1,810 QTY 6,83 4.200 20.690P5100 CTN
2020092427713Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyGLOVES 18051.340 KGS 60 CBM SHIPPER LOAD, COUNT AND SEALED 1 X 40'HC 2282 CASES FOB PORT KLANG, MALAYSIA 2282 CASES2282 CAS
2020092423731Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey240 CTN 240 QTY 781.390 2.740PO NO.: 1055059G LOVE, NITRILE PF, S, (HTS# 4015191010)SKU NO. 4882671,480 CTN 1,480 QTY 5,173.780 16.920PO NO.: 1055059GLOVE, NITRILE PF, M, (HTS# 4015 191010)SKU NO. 4882781,810 CTN 1,810 QTY 6,83 4.200 20.690P5100 CTN
202009239283Singapore,Singapore -> New York/Newark Area, Newark, New JerseyGLOVES2282 CAS
202009238840Vung Tau,Vietnam -> Long Beach, CaliforniaRUBBER GLOVES3600 CAS
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