Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Brightway Holdings Sdn. Bhd. · Predicate Candidate Screening

24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

59 daysmedian FDA review time

239 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K211816	Brightway Brand, Nitrile Examination Gloves, Powder Free (Bl	Brightway Holdings Sdn. Bhd.	2022-11-02	509
K170686	Nitrile Examination Gloves, Powder Free [Purple] Tested for	Brightway Holdings Sdn. Bhd.	2017-07-14	129
K162294	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE,	Brightway Holdings Sdn. Bhd.	2017-04-21	249
K162186	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE,	Brightway Holdings Sdn. Bhd.	2017-03-31	239
K163267	NITRILE EXAMINATION GLOVE	Brightway Holdings Sdn. Bhd.	2017-03-24	123
K162146	Brightway Brand Nitrile Examination Gloves, Powder Free (Lav	Brightway Holdings Sdn. Bhd.	2017-01-05	157
K161215	Brightway Brand Nitrile Examination Gloves, Powder Free, [St	Brightway Holdings Sdn. Bhd.	2016-12-21	236
K102880	BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE,	Brightway Holdings Sdn. Bhd.	2010-11-19	50
K060402	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLAC	Brightway Holdings Sdn. Bhd.	2006-06-09	114
K060658	BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK	Brightway Holdings Sdn. Bhd.	2006-04-10	54
K032940	BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERIL	Brightway Holdings Sdn. Bhd.	2003-11-20	59
K032938	BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE),	Brightway Holdings Sdn. Bhd.	2003-11-20	59
K022878	BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOV	Brightway Holdings Sdn. Bhd.	2002-09-17	18
K011728	BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE N	Brightway Holdings Sdn. Bhd.	2001-07-09	35
K010856	STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES	Brightway Holdings Sdn. Bhd.	2001-06-06	76
K991940	BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)	Brightway Holdings Sdn. Bhd.	1999-07-12	33
K991939	BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FR	Brightway Holdings Sdn. Bhd.	1999-07-01	22
K990876	BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)	Brightway Holdings Sdn. Bhd.	1999-06-23	99
K990878	BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE	Brightway Holdings Sdn. Bhd.	1999-05-21	66
K990539	BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)	Brightway Holdings Sdn. Bhd.	1999-04-09	46
K990542	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)	Brightway Holdings Sdn. Bhd.	1999-04-09	46
K990541	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)	Brightway Holdings Sdn. Bhd.	1999-04-09	46
K990540	BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)	Brightway Holdings Sdn. Bhd.	1999-04-09	46
K990543	BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWD	Brightway Holdings Sdn. Bhd.	1999-04-09	46

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda