FDA 510(k)

Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color

Número K: K210388 · 2021-12-13

Data da decisão2021-12-13

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color is the device name listed in this FDA 510(k) record. The listed applicant is Mexpo International, Inc.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K210388. 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 Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color?

Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Mexpo International, Inc.. The 510(k) number is K210388.

When did Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color receive FDA 510(k) clearance?

Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color received FDA 510(k) clearance on 2021-12-13, under 510(k) number K210388.

Who is the listed applicant for Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color?

The FDA 510(k) record lists Mexpo International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color?

The FDA product code for Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color is LZA.

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