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FDA 510(k)

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

K-Number: K162186 · 2017-03-31

ApplicantBrightway Holdings Sdn. Bhd.
Decision Date2017-03-31
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a medical device manufactured by Brightway Holdings Sdn. Bhd.. It received FDA 510(k) clearance on 2017-03-31 under approval number K162186. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Brightway Holdings Sdn. Bhd.. The 510(k) number is K162186.

When was BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM approved by the FDA?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM received FDA 510(k) clearance on 2017-03-31, under approval number K162186.

What company makes BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is manufactured by Brightway Holdings Sdn. Bhd..

What is the FDA product code for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM?

The FDA product code for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is LZC.

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Other Devices by Brightway Holdings Sdn. Bhd.

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Related Devices (Code: LZC)

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Official Source

View on FDA Database →

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

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