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FDA 510(k)

Disposable Nitrile Examination Gloves

K-Number: K211073 · 2021-09-21

ApplicantFoshan Kangkang Biotechnology Co., Ltd.
Decision Date2021-09-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Examination Gloves is a medical device manufactured by Foshan Kangkang Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-21 under approval number K211073. 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 Disposable Nitrile Examination Gloves?

Disposable Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-09-21. It is manufactured by Foshan Kangkang Biotechnology Co., Ltd.. The 510(k) number is K211073.

When was Disposable Nitrile Examination Gloves approved by the FDA?

Disposable Nitrile Examination Gloves received FDA 510(k) clearance on 2021-09-21, under approval number K211073.

What company makes Disposable Nitrile Examination Gloves?

Disposable Nitrile Examination Gloves is manufactured by Foshan Kangkang Biotechnology Co., Ltd..

What is the FDA product code for Disposable Nitrile Examination Gloves?

The FDA product code for Disposable Nitrile Examination Gloves is 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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