Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Brightsway Holdings Sdn Bhd

Klang Selangor Darul Ehsan, MY

Brightsway Holdings Sdn Bhd appears in FDA device records in Klang Selangor Darul Ehsan, MY. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 4 510(k) clearances for Brightsway Holdings Sdn Bhd in 1999.

Clearances by year, as a table
510(k) clearance decisions for Brightsway Holdings Sdn Bhd, by decision year
YearClearances
19994
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K992020BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)KGOSubstantially Equivalent
K992021BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)KGOSubstantially Equivalent
K991752BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PELYYSubstantially Equivalent
K991750BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEINLYYSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Brightsway Holdings Sdn Bhd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Brightsway Holdings Sdn Bhd. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of , FDA export datePage updated Source: openFDA, public domain