FDA 510(k)

BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)

K-Number: K992020 · 1999-07-26

Decision Date1999-07-26

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) is the device name listed in this FDA 510(k) record. The listed applicant is Brightsway Holdings Sdn Bhd. It received FDA 510(k) clearance on 1999-07-26 under 510(k) number K992020. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)?

BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) is a medical device that received FDA 510(k) clearance on 1999-07-26. The listed applicant is Brightsway Holdings Sdn Bhd. The 510(k) number is K992020.

When did BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) receive FDA 510(k) clearance?

BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) received FDA 510(k) clearance on 1999-07-26, under 510(k) number K992020.

Who is the listed applicant for BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)?

The FDA 510(k) record lists Brightsway Holdings Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)?

The FDA product code for BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) is KGO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Brightsway Holdings Sdn Bhd as applicant

K992021BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)K991752BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE K991750BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN

Related Devices (Code: KGO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.