Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617444

FEI Number

1000153304

Entity Name

BRIGHTWAY HOLDINGS SDN. BHD.

City/State/Country

KLANG, Selangor, MY

Establishment Address

LOT 1559, JALAN ISTIMEWA,, BATU BELAH, KLANG, Selangor 42100, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BRIGHTWAY HOLDINGS SDN. BHD. (Owner Number: 9036471)

Owner / Operator Contact Address

LOT 1559, JALAN ISTIMEWA,, BATU BELAH, KLANG, SELANGOR, MY-NOTA 42100, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102880

PMA Number

N/A

All Registered Proprietary Names

BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND CTI International BRIGHTWAY BRAND Diamond M Latex Examination Powder Free Gloves BRIGHTWAY BRAND BRIGHTWAY BRAND BRIGHTWAY BRAND

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-03-26
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2019-03-26
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-12-14
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-06-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-06-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-12-14
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-06-06
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-06-06
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-06-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-12-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-09-07

Official Correspondent

BASKARAN GOVINDASAMY

US Agent Details

Jerry Doane Doane Business: FDABasics LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

BRIGHTWAY HOLDINGS SDN. BHD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617444. Last updated year: 2026. Please use registration number 9617444 when referencing this establishment in official correspondence.