FDA 510(k)

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

Número K: K220121 · 2022-04-11

Data da decisão2022-04-11

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black is the device name listed in this FDA 510(k) record. The listed applicant is Aamedix Glove Sdn Bhd. It received FDA 510(k) clearance on 2022-04-11 under 510(k) number K220121. 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?

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black is a medical device that received FDA 510(k) clearance on 2022-04-11. The listed applicant is Aamedix Glove Sdn Bhd. The 510(k) number is K220121.

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

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black received FDA 510(k) clearance on 2022-04-11, under 510(k) number K220121.

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

The FDA 510(k) record lists Aamedix Glove Sdn Bhd 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?

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

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Fonte oficial

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