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FDA 510(k)

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)

K-Number: K211457 · 2021-12-18

ApplicantAmmex Corporation
Decision Date2021-12-18
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a medical device manufactured by Ammex Corporation. It received FDA 510(k) clearance on 2021-12-18 under approval number K211457. 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 Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)?

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a medical device that received FDA 510(k) clearance on 2021-12-18. It is manufactured by Ammex Corporation. The 510(k) number is K211457.

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

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) received FDA 510(k) clearance on 2021-12-18, under approval number K211457.

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

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is manufactured by Ammex Corporation.

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

The FDA product code for Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is LZA.

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Related Devices (Code: 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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