FDA 510(k)

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

Número K: K211457 · 2021-12-18

Data da decisão2021-12-18

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is the device name listed in this FDA 510(k) record. The listed applicant is Ammex Corporation. It received FDA 510(k) clearance on 2021-12-18 under 510(k) number K211457. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Ammex Corporation. The 510(k) number is K211457.

When did Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) receive FDA 510(k) clearance?

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

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)?

The FDA 510(k) record lists Ammex Corporation as the applicant. This does not by itself establish the device manufacturer.

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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