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FDA 510(k)

Nitrile Examination Gloves Powder Free (Blue)

K-Number: K210868 · 2021-09-02

ApplicantGreat Eco Glove Sdn. Bhd.
Decision Date2021-09-02
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Examination Gloves Powder Free (Blue) is a medical device manufactured by Great Eco Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-09-02 under approval number K210868. 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 Powder Free (Blue)?

Nitrile Examination Gloves Powder Free (Blue) is a medical device that received FDA 510(k) clearance on 2021-09-02. It is manufactured by Great Eco Glove Sdn. Bhd.. The 510(k) number is K210868.

When was Nitrile Examination Gloves Powder Free (Blue) approved by the FDA?

Nitrile Examination Gloves Powder Free (Blue) received FDA 510(k) clearance on 2021-09-02, under approval number K210868.

What company makes Nitrile Examination Gloves Powder Free (Blue)?

Nitrile Examination Gloves Powder Free (Blue) is manufactured by Great Eco Glove Sdn. Bhd..

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

The FDA product code for Nitrile Examination Gloves Powder Free (Blue) 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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