FDA 510(k)

Disposable Nitrile Examination Gloves

Número K: K203805 · 2021-04-20

RequerenteJiangsu Yanfang Medical Technology Co., Ltd.

Data da decisão2021-04-20

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yanfang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-04-20 under 510(k) number K203805. 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 Disposable Nitrile Examination Gloves?

Disposable Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-04-20. The listed applicant is Jiangsu Yanfang Medical Technology Co., Ltd.. The 510(k) number is K203805.

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

Disposable Nitrile Examination Gloves received FDA 510(k) clearance on 2021-04-20, under 510(k) number K203805.

Who is the listed applicant for Disposable Nitrile Examination Gloves?

The FDA 510(k) record lists Jiangsu Yanfang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Examination Gloves?

The FDA product code for Disposable Nitrile Examination Gloves is LZA.

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