FDA 510(k)

Nitrile Powder Free Blue Examination Gloves, Non-Sterile

Número K: K212535 · 2021-12-04

Data da decisão2021-12-04

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Powder Free Blue Examination Gloves, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2021-12-04 under 510(k) number K212535. 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 Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

Nitrile Powder Free Blue Examination Gloves, Non-Sterile is a medical device that received FDA 510(k) clearance on 2021-12-04. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. The 510(k) number is K212535.

When did Nitrile Powder Free Blue Examination Gloves, Non-Sterile receive FDA 510(k) clearance?

Nitrile Powder Free Blue Examination Gloves, Non-Sterile received FDA 510(k) clearance on 2021-12-04, under 510(k) number K212535.

Who is the listed applicant for Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

The FDA 510(k) record lists Mah Sing Healthcare Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

The FDA product code for Nitrile Powder Free Blue Examination Gloves, Non-Sterile is LZA.

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Outros registros que listam Mah Sing Healthcare Sdn. Bhd. como candidato(a)

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Dispositivos Relacionados (Código: LZA)

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