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FDA 510(k)

Powder Free Nitrile Examination Gloves (White, Blue and Black)

K-Number: K212998 · 2022-02-19

ApplicantAlcatron Gloves Factory
Decision Date2022-02-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves (White, Blue and Black) is a medical device manufactured by Alcatron Gloves Factory. It received FDA 510(k) clearance on 2022-02-19 under approval number K212998. 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 Powder Free Nitrile Examination Gloves (White, Blue and Black)?

Powder Free Nitrile Examination Gloves (White, Blue and Black) is a medical device that received FDA 510(k) clearance on 2022-02-19. It is manufactured by Alcatron Gloves Factory. The 510(k) number is K212998.

When was Powder Free Nitrile Examination Gloves (White, Blue and Black) approved by the FDA?

Powder Free Nitrile Examination Gloves (White, Blue and Black) received FDA 510(k) clearance on 2022-02-19, under approval number K212998.

What company makes Powder Free Nitrile Examination Gloves (White, Blue and Black)?

Powder Free Nitrile Examination Gloves (White, Blue and Black) is manufactured by Alcatron Gloves Factory.

What is the FDA product code for Powder Free Nitrile Examination Gloves (White, Blue and Black)?

The FDA product code for Powder Free Nitrile Examination Gloves (White, Blue and Black) is LZA.

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Related Devices (Code: LZA)

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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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