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FDA 510(k)

ELAZ Nitrile Powder Free Examination Glove

Número K: K213604 · 2022-04-03

RequerenteProtect Gloves Co., Ltd.
Data da decisão2022-04-03
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

ELAZ Nitrile Powder Free Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Protect Gloves Co., Ltd.. It received FDA 510(k) clearance on 2022-04-03 under 510(k) number K213604. 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 ELAZ Nitrile Powder Free Examination Glove?

ELAZ Nitrile Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2022-04-03. The listed applicant is Protect Gloves Co., Ltd.. The 510(k) number is K213604.

When did ELAZ Nitrile Powder Free Examination Glove receive FDA 510(k) clearance?

ELAZ Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2022-04-03, under 510(k) number K213604.

Who is the listed applicant for ELAZ Nitrile Powder Free Examination Glove?

The FDA 510(k) record lists Protect Gloves Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELAZ Nitrile Powder Free Examination Glove?

The FDA product code for ELAZ Nitrile Powder Free Examination Glove is LZA.

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Dispositivos Relacionados (Código: LZA)

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