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FDA 510(k)

Blue Nitrile Exam Glove, Powder Free

K-Number: K210058 · 2021-03-30

ApplicantGreat Harvest Trading Co., Ltd.
Decision Date2021-03-30
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Blue Nitrile Exam Glove, Powder Free is a medical device manufactured by Great Harvest Trading Co., Ltd.. It received FDA 510(k) clearance on 2021-03-30 under approval number K210058. 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 Blue Nitrile Exam Glove, Powder Free?

Blue Nitrile Exam Glove, Powder Free is a medical device that received FDA 510(k) clearance on 2021-03-30. It is manufactured by Great Harvest Trading Co., Ltd.. The 510(k) number is K210058.

When was Blue Nitrile Exam Glove, Powder Free approved by the FDA?

Blue Nitrile Exam Glove, Powder Free received FDA 510(k) clearance on 2021-03-30, under approval number K210058.

What company makes Blue Nitrile Exam Glove, Powder Free?

Blue Nitrile Exam Glove, Powder Free is manufactured by Great Harvest Trading Co., Ltd..

What is the FDA product code for Blue Nitrile Exam Glove, Powder Free?

The FDA product code for Blue Nitrile Exam Glove, Powder Free is LZA.

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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.

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