Gallant Quality Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Gallant Quality 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 Number9613998
FEI Number3006581410
NameGALLANT QUALITY SDN. BHD.
Owner & OperatorGALLANT QUALITY SDN BHD
Contact AddressLOT 1874, JALAN KAMPUNG DEW --
TAIPING, PERAK MY-NOTA 34700 MY
Official Correspondent
  • KEVIN - LEE
  • 60-5849-4931-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLOT 1874, JALAN KAMPUNG DEW
TAIPING, PERAK Perak, 34700 MY
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
GALLANT QUALITY SDN. BHD. [GALLANT QUALITY SDN BHD]
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labelling Claim2018-06-26
GALLANT QUALITY SDN. BHD. [GALLANT QUALITY SDN BHD]
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labelling Claim2018-06-26
GALLANT QUALITY SDN. BHD. [GALLANT QUALITY SDN BHD]
Powder-Free Blue Nitrile Examination Gloves with Tested For Use with Chemotherapy Drugs Labeling Claim2018-03-22
GALLANT QUALITY SDN. BHD. [GALLANT QUALITY SDN BHD]
Powder Free Nitrile (Black) Examination Gloves2015-12-11
GALLANT QUALITY SDN. BHD.
Powder Free Nitrile (Black) Examination Gloves2015-10-09
GALLANT QUALITY SDN. BHD. [GALLANT QUALITY SDN BHD]
Nitrile Examination Gloves2011-01-07
GALLANT QUALITY SDN. BHD. [GALLANT QUALITY SDN BHD]
NITRILE EXAMINATION GLOVES2009-01-12
GALLANT QUALITY SDN. BHD. [GALLANT QUALITY SDN BHD]
Powdered Latex Examination Gloves1998-03-19
GALLANT QUALITY SDN. BHD. [GALLANT QUALITY SDN BHD]
PATIENT PF LATEX EXAMINATION GLOVES1998-03-19

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009248704Kaohsiung,China (Taiwan) -> Seattle, WashingtonLATEX GLOVE 1 X 40'GP CONTAINER CONTAIN - 3,500CTNS OF NITRILE PF EXAM GLOVES INVOICE NO GEI/2107/006 PO NO BR131086 HS CODE 4015190090 THIS SHIPMENT CONTAINS NO SOLID WOOD3500 CTN
2020092420623Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyRUBBER GLOVE2400 CTN
2020091911230Port Swettenham,Malaysia -> Savannah, GeorgiaLATEX GLOVES 1 X 40'GP CONTAINER TO CONTAIN - 3,500 CTNS OF NITRILE PF EXAM GLOVES INVOICE NO GEI/2107/001 PO NO BR71252 HS CODE 4015190090 THIS SHIPMENT CONTAINS NO SOLID WOOD3500 CTN
202009183593Kaohsiung,China (Taiwan) -> Savannah, GeorgiaLATEX GLOVE 1 X 40'GP CONTAINER TO CONTAIN - 1,760 CTNS OF NITRILE PF EXAM GLOVES INVOICE NO GEI/2106/054 PO NO BR131385 HS CODE 4015190090 THIS SHIPMENT CONTAINS NO SOLID WOOD1760 CTN
202009171617Shanghai ,China (Mainland) -> Miami, FloridaNITRILE PF EXAM GLOVES2213 CTN
202009154756Xiamen,China (Mainland) -> Los Angeles, California1X40ST CONTAINER OF 2,997 CARTONS OF NITRILE PF EXAM GLOVES AND PACKAGING MATERIAL : 12 PC S CARTONS 40 PCS DISPENSERS PO NO.: 5601 HS CODE: 4015.19 ON DECK SHIPMENT IS NOT ALLOWE D, AWAY FROM BOILER & HEAT FREIGHT COLLECT2997 CTN
2020091413856Singapore,Singapore -> Oakland, California2,657 CARTONS OF NITRILE PF DISPOSABLE GLOVES NITRILE PF EXAM GLOVES AND PACKAGING MATERIALS 10 PCS CARTONS 50 PCS DISPENSERS PO NO. 1I4390-5 HS CODE 4015.19, 4819.10 4819.20 FREIGHT COLLECT NOTIFY PARTY 3 C.H. ROBINSON INTERNATIONAL, INC. - CHICAGO BRANCH 1501 N MITTEL BLVD., WOOD DALE, IL 60191-10552657 CTN
2020091424379Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyRUBBER GLOVE2400 CTN

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