FDA 510(k)

Disposable Nitrile Examination Glove

Número K: K212661 · 2021-11-19

RequerenteInner Mongolia Cureguard Medical Technology Co., Ltd.

Data da decisão2021-11-19

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Nitrile Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K212661. 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 Glove?

Disposable Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. The 510(k) number is K212661.

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

Disposable Nitrile Examination Glove received FDA 510(k) clearance on 2021-11-19, under 510(k) number K212661.

Who is the listed applicant for Disposable Nitrile Examination Glove?

The FDA 510(k) record lists Inner Mongolia Cureguard 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 Glove?

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

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Outros registros que listam Inner Mongolia Cureguard Medical Technology Co., Ltd. como candidato(a)

K222642Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)K212401Disposable Nitrile Examination Glove

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