FDA 510(k)

Nitrile Exam Gloves, Powder Free, Blue

Número K: K211699 · 2021-08-20

RequerenteHengchang (Dongying) Medical Technology Co., Ltd.

Data da decisão2021-08-20

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Exam Gloves, Powder Free, Blue is the device name listed in this FDA 510(k) record. The listed applicant is Hengchang (Dongying) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K211699. 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 Exam Gloves, Powder Free, Blue?

Nitrile Exam Gloves, Powder Free, Blue is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Hengchang (Dongying) Medical Technology Co., Ltd.. The 510(k) number is K211699.

When did Nitrile Exam Gloves, Powder Free, Blue receive FDA 510(k) clearance?

Nitrile Exam Gloves, Powder Free, Blue received FDA 510(k) clearance on 2021-08-20, under 510(k) number K211699.

Who is the listed applicant for Nitrile Exam Gloves, Powder Free, Blue?

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

What is the FDA product code for Nitrile Exam Gloves, Powder Free, Blue?

The FDA product code for Nitrile Exam Gloves, Powder Free, Blue is LZA.

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Outros registros que listam Hengchang (Dongying) Medical Technology Co., Ltd. como candidato(a)

K211714Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)

Dispositivos Relacionados (Código: LZA)

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