FDA 510(k)

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

Número K: K212789 · 2021-12-01

Requerente5r Med Instruments (Chengdu) Co., Ltd.

Data da decisão2021-12-01

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is 5r Med Instruments (Chengdu) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-01 under 510(k) number K212789. 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 (Tested for Use with Chemotherapy Drugs)?

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is 5r Med Instruments (Chengdu) Co., Ltd.. The 510(k) number is K212789.

When did Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-12-01, under 510(k) number K212789.

Who is the listed applicant for Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA 510(k) record lists 5r Med Instruments (Chengdu) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is LZA.

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Outros registros que listam 5r Med Instruments (Chengdu) Co., Ltd. como candidato(a)

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