Brightway Holdings Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Brightway Holdings 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 Number3013546409
FEI Number3013546409
NameBRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2)
Owner & OperatorBRIGHTWAY HOLDINGS SDN. BHD.
Contact AddressLOT 1559, JALAN ISTIMEWA, BATU BELAH
KLANG, SELANGOR MY-NOTA 42100 MY
Official Correspondent
  • BASKARAN - GOVINDASAMY
  • 60-3-3431007-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPT4250 & PT4251, SOLOK SULTAN HISHAMUDDIN 7, KAW. 20, PELABUHAN KLANG UTARA K/U 17,
KLANG, SELANGOR Selangor, 42100 MY
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



Registration Number9617444
FEI Number1000153304
NameJerry Doane
Owner & OperatorBRIGHTWAY HOLDINGS SDN. BHD.
Contact AddressLOT 1559, JALAN ISTIMEWA, BATU BELAH
KLANG, SELANGOR MY-NOTA 42100 MY
Official Correspondent
  • BASKARAN - GOVINDASAMY
  • 60-3-3431007-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address15815 SW 11th Court Rd.
Ocala, FL 34473 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Brightway Holdings Sdn. Bhd.
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested For Use With Chemotherapy Drugs And Fentanyl Citrate2022-11-02
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Holdings Sdn Bhd2019-03-26
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Holdings Sdn Bhd2019-03-26
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Holdings Sdn Bhd2019-03-26
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Holdings Sdn Bhd2019-03-26
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
Kimberly-Clark Global Sales2018-10-29
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Holdings Sdn Bhd2018-10-29
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
Kimberly-Clark Global Sales2018-10-29
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Holdings Sdn Bhd2018-10-29
Brightway Holdings Sdn. Bhd.
Nitrile Examination Gloves, Powder Free [Purple] Tested For Use With Chemotherapy Drugs2017-07-14
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Nitrile Examination Glove, Powder Free (Blue)2017-06-06
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Nitrile Examination Glove, Powder Free (Blue)2017-06-06
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs2017-06-06
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs2017-06-06
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs2017-06-06
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs2017-06-06
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Brand Nitrile Examination Gloves 12", Powder Free, (Sterling/Grey) Tested for use with Chemotherapy Drugs2017-06-06
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
Brightway Brand Nitrile Examination Gloves 12", Powder Free, (Sterling/Grey) Tested for use with Chemotherapy Drugs2017-06-06
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BrightwayBrand Nitrile Examination Gloves, Powder Free (Lavender)2017-06-06
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BrightwayBrand Nitrile Examination Gloves, Powder Free (Lavender)2017-06-06
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs2017-06-06
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs2017-06-06
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs2017-06-06
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs2017-06-06
BRIGHTWAY HOLDINGS SDN BHD.
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS2017-04-21
BRIGHTWAY HOLDINGS SDN BHD
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM2017-03-31
BRIGHTWAY HOLDINGS SDN BHD
NITRILE EXAMINATION GLOVE2017-03-24
BRIGHTWAY HOLDINGS SDN BHD.
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)2017-01-05
BRIGHTWAY HOLDINGS SDN BHD
Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs2016-12-21
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)2010-11-19
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]
BRIGHTWAY BRAND2007-12-14
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)2006-06-09
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)2006-04-10
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)2002-09-17
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)1999-07-12
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)1999-07-01
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)1999-06-23
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)1999-05-21
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)1999-04-09
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)1999-04-09
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)1999-04-09
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)1999-04-09
BRIGHTWAY HOLDINGS SDN. BHD.
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)1999-04-09

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092923834Singapore,Singapore -> New York/Newark Area, Newark, New JerseyRUBBER GLOVES2193 CTN
2020092520709Singapore,Singapore -> New York/Newark Area, Newark, New JerseyRUBBER GLOVES2193 CTN
202009228231Suez,Egypt -> Savannah, GeorgiaNITRILE DISPOSABLE GLOVES2150 CTN
202009219634Suez,Egypt -> Savannah, GeorgiaNITRILE DISPOSABLE GLOVES2150 CTN
2020091743365Port Swettenham,Malaysia -> Los Angeles, CaliforniaNITRILE EXAMINATION GLOVES2000 CTN
202009119244Xiamen,China (Mainland) -> Long Beach, CaliforniaRUBBER GLOVE896 CTN
202009107506Xiamen,China (Mainland) -> Long Beach, CaliforniaRUBBER GLOVE896 CTN
2020090510942Xiamen,China (Mainland) -> Long Beach, CaliforniaRUBBER GLOVE896 CTN

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