FDA 510(k)

Medical Gloves

Número K: K203622 · 2021-08-20

RequerenteBeijing Biosis Healing Biolog Ical Technology Co., Ltd.

Data da decisão2021-08-20

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K203622. 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 Medical Gloves?

Medical Gloves is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. The 510(k) number is K203622.

When did Medical Gloves receive FDA 510(k) clearance?

Medical Gloves received FDA 510(k) clearance on 2021-08-20, under 510(k) number K203622.

Who is the listed applicant for Medical Gloves?

The FDA 510(k) record lists Beijing Biosis Healing Biolog Ical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Gloves?

The FDA product code for Medical Gloves is LZA.

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