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FDA 510(k)

Nitrile Examination Gloves

Número K: K211515 · 2021-08-24

RequerenteBeijing Reagent Latex Products Co., Ltd.
Data da decisão2021-08-24
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Reagent Latex Products Co., Ltd.. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K211515. 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 Examination Gloves?

Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Beijing Reagent Latex Products Co., Ltd.. The 510(k) number is K211515.

When did Nitrile Examination Gloves receive FDA 510(k) clearance?

Nitrile Examination Gloves received FDA 510(k) clearance on 2021-08-24, under 510(k) number K211515.

Who is the listed applicant for Nitrile Examination Gloves?

The FDA 510(k) record lists Beijing Reagent Latex Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Gloves?

The FDA product code for Nitrile Examination Gloves is LZA.

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Dispositivos Relacionados (Código: LZA)

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Fonte oficial

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