Brightway Holdings Sdn. Bhd. is one of 79 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Brightway Holdings Sdn. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs, BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
24
Total
24
Cleared
0
Denied
Brightway Holdings Sdn. Bhd. has 24 FDA 510(k) cleared general hospital devices. Based in Klang, Selangor Darul Ehsan, MY.
Last cleared in 2022. Active since 1999.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Truscott Medsci Associates, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Brightway Holdings Sdn. Bhd.
24 devices
Cleared
Nov 02, 2022
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for...
General Hospital
509d
Cleared
Jul 14, 2017
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with...
General Hospital
129d
Cleared
Apr 21, 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED...
General Hospital
249d
Cleared
Mar 31, 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY]...
General Hospital
239d
Cleared
Mar 24, 2017
NITRILE EXAMINATION GLOVE
General Hospital
123d
Cleared
Jan 05, 2017
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
General Hospital
157d
Cleared
Dec 21, 2016
Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey]...
General Hospital
236d
Cleared
Nov 19, 2010
BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE....
General Hospital
50d
Cleared
Jun 09, 2006
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
General Hospital
114d
Cleared
Apr 10, 2006
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
General Hospital
54d
Cleared
Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150...
General Hospital
59d
Cleared
Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50...
General Hospital
59d