FDA 510(k)

Nitrile Examination Gloves, Green/ Blue/ Black Color

Número K: K211778 · 2021-09-02

RequerenteZhenjiang Suhui Latex Products Co., Ltd.

Data da decisão2021-09-02

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Examination Gloves, Green/ Blue/ Black Color is the device name listed in this FDA 510(k) record. The listed applicant is Zhenjiang Suhui Latex Products Co., Ltd.. It received FDA 510(k) clearance on 2021-09-02 under 510(k) number K211778. 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, Green/ Blue/ Black Color?

Nitrile Examination Gloves, Green/ Blue/ Black Color is a medical device that received FDA 510(k) clearance on 2021-09-02. The listed applicant is Zhenjiang Suhui Latex Products Co., Ltd.. The 510(k) number is K211778.

When did Nitrile Examination Gloves, Green/ Blue/ Black Color receive FDA 510(k) clearance?

Nitrile Examination Gloves, Green/ Blue/ Black Color received FDA 510(k) clearance on 2021-09-02, under 510(k) number K211778.

Who is the listed applicant for Nitrile Examination Gloves, Green/ Blue/ Black Color?

The FDA 510(k) record lists Zhenjiang Suhui 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, Green/ Blue/ Black Color?

The FDA product code for Nitrile Examination Gloves, Green/ Blue/ Black Color is LZA.

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