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FDA 510(k)

Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)

K-Number: K162146 · 2017-01-05

Decision Date2017-01-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) is the device name listed in this FDA 510(k) record. The listed applicant is Brightway Holdings Sdn. Bhd.. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K162146. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)?

Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Brightway Holdings Sdn. Bhd.. The 510(k) number is K162146.

When did Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) receive FDA 510(k) clearance?

Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) received FDA 510(k) clearance on 2017-01-05, under 510(k) number K162146.

Who is the listed applicant for Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)?

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

What is the FDA product code for Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)?

The FDA product code for Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) is LZA.

Other records listing Brightway Holdings Sdn. Bhd. as applicant

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.

View all 7 devices →

Related Devices (Code: LZA)

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.

Official Source

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