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FDA 510(k)

Nitrile Examination Gloves

K-Number: K212551 · 2021-11-05

Decision Date2021-11-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Examination Gloves is a medical device manufactured by Anhui Fine Glove Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-05 under approval number K212551. 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 Nitrile Examination Gloves?

Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Anhui Fine Glove Medical Technology Co., Ltd.. The 510(k) number is K212551.

When was Nitrile Examination Gloves approved by the FDA?

Nitrile Examination Gloves received FDA 510(k) clearance on 2021-11-05, under approval number K212551.

What company makes Nitrile Examination Gloves?

Nitrile Examination Gloves is manufactured by Anhui Fine Glove Medical Technology Co., Ltd..

What is the FDA product code for Nitrile Examination Gloves?

The FDA product code for Nitrile Examination Gloves is LZA.

Related Clinical Trials

Related Devices (Code: LZA)

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.