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 Number: 3013546409
• FEI Number: 3013546409
• Name: BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2)
• Owner & Operator: BRIGHTWAY HOLDINGS SDN. BHD.
• Contact Address: LOT 1559, JALAN ISTIMEWA, BATU BELAH; KLANG, SELANGOR MY-NOTA 42100 MY
• Official Correspondent:
  • BASKARAN - GOVINDASAMY
  • 60-3-3431007-x
• US Agent:
  • Jerry Doane
  • 716 7750533
  • jdoane@usagent-tobias.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: PT4250 & 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 Number: 9617444
• FEI Number: 1000153304
• Name: Jerry Doane
• Owner & Operator: BRIGHTWAY HOLDINGS SDN. BHD.
• Contact Address: LOT 1559, JALAN ISTIMEWA, BATU BELAH; KLANG, SELANGOR MY-NOTA 42100 MY
• Official Correspondent:
  • BASKARAN - GOVINDASAMY
  • 60-3-3431007-x
• US Agent:
  • Jerry Doane
  • Pragmatic Compliance LLC
  • 716 7750533
  • jdoane@usagent-tobias.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 15815 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	Device	Date
PMN K211816 Brightway Holdings Sdn. Bhd.	Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested For Use With Chemotherapy Drugs And Fentanyl Citrate	2022-11-02
PMN K170686 | LZC Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Holdings Sdn Bhd	2019-03-26
PMN K170686 | LZC BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Holdings Sdn Bhd	2019-03-26
PMN K170686 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Holdings Sdn Bhd	2019-03-26
PMN K170686 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Holdings Sdn Bhd	2019-03-26
PMN K994281 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	Kimberly-Clark Global Sales	2018-10-29
PMN K994281 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Holdings Sdn Bhd	2018-10-29
PMN K994281 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Kimberly-Clark Global Sales	2018-10-29
PMN K994281 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Holdings Sdn Bhd	2018-10-29
PMN K170686 Brightway Holdings Sdn. Bhd.	Nitrile Examination Gloves, Powder Free [Purple] Tested For Use With Chemotherapy Drugs	2017-07-14
PMN K163267 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Nitrile Examination Glove, Powder Free (Blue)	2017-06-06
PMN K163267 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Nitrile Examination Glove, Powder Free (Blue)	2017-06-06
PMN K162294 | LZC Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs	2017-06-06
PMN K162294 | LZC BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs	2017-06-06
PMN K162294 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs	2017-06-06
PMN K162294 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs	2017-06-06
PMN K162186 | LZC Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Brand Nitrile Examination Gloves 12", Powder Free, (Sterling/Grey) Tested for use with Chemotherapy Drugs	2017-06-06
PMN K162186 | LZC 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 Drugs	2017-06-06
PMN K162146 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BrightwayBrand Nitrile Examination Gloves, Powder Free (Lavender)	2017-06-06
PMN K162146 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BrightwayBrand Nitrile Examination Gloves, Powder Free (Lavender)	2017-06-06
PMN K161215 | LZC Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs	2017-06-06
PMN K161215 | LZC BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs	2017-06-06
PMN K161215 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs	2017-06-06
PMN K161215 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs	2017-06-06
PMN K162294 BRIGHTWAY HOLDINGS SDN BHD.	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS	2017-04-21
PMN K162186 BRIGHTWAY HOLDINGS SDN BHD	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM	2017-03-31
PMN K163267 BRIGHTWAY HOLDINGS SDN BHD	NITRILE EXAMINATION GLOVE	2017-03-24
PMN K162146 BRIGHTWAY HOLDINGS SDN BHD.	Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)	2017-01-05
PMN K161215 BRIGHTWAY HOLDINGS SDN BHD	Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs	2016-12-21
PMN K102880 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)	2010-11-19
PMN K992021 | KGO Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K992021 | KGO BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K991939 | KGO Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K991939 | KGO BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K990878 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K990878 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K990540 | LYY Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K990540 | LYY BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K990539 | LYY Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K990539 | LYY BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K060402 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K060402 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K022878 | LZA Jerry Doane [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K022878 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K060402 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)	2006-06-09
PMN K060658 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)	2006-04-10
PMN K022878 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)	2002-09-17
PMN K991940 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)	1999-07-12
PMN K991939 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)	1999-07-01
PMN K990876 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)	1999-06-23
PMN K990878 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)	1999-05-21
PMN K990543 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)	1999-04-09
PMN K990542 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)	1999-04-09
PMN K990541 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)	1999-04-09
PMN K990540 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)	1999-04-09
PMN K990539 BRIGHTWAY HOLDINGS SDN. BHD.	BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)	1999-04-09

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092923834	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	RUBBER GLOVES	2193 CTN
2020092520709	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	RUBBER GLOVES	2193 CTN
202009228231	Suez,Egypt -> Savannah, Georgia	NITRILE DISPOSABLE GLOVES	2150 CTN
202009219634	Suez,Egypt -> Savannah, Georgia	NITRILE DISPOSABLE GLOVES	2150 CTN
2020091743365	Port Swettenham,Malaysia -> Los Angeles, California	NITRILE EXAMINATION GLOVES	2000 CTN
202009119244	Xiamen,China (Mainland) -> Long Beach, California	RUBBER GLOVE	896 CTN
202009107506	Xiamen,China (Mainland) -> Long Beach, California	RUBBER GLOVE	896 CTN
2020090510942	Xiamen,China (Mainland) -> Long Beach, California	RUBBER GLOVE	896 CTN