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FDA 510(k)

ELAZ Nitrile Powder Free Examination Glove

K-Number: K213604 · 2022-04-03

ApplicantProtect Gloves Co., Ltd.
Decision Date2022-04-03
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELAZ Nitrile Powder Free Examination Glove is a medical device manufactured by Protect Gloves Co., Ltd.. It received FDA 510(k) clearance on 2022-04-03 under approval number K213604. 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 ELAZ Nitrile Powder Free Examination Glove?

ELAZ Nitrile Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2022-04-03. It is manufactured by Protect Gloves Co., Ltd.. The 510(k) number is K213604.

When was ELAZ Nitrile Powder Free Examination Glove approved by the FDA?

ELAZ Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2022-04-03, under approval number K213604.

What company makes ELAZ Nitrile Powder Free Examination Glove?

ELAZ Nitrile Powder Free Examination Glove is manufactured by Protect Gloves Co., Ltd..

What is the FDA product code for ELAZ Nitrile Powder Free Examination Glove?

The FDA product code for ELAZ Nitrile Powder Free Examination Glove 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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