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FDA 510(k)

BIOTECH Nitrile Examination Gloves

Número K: K202419 · 2021-04-16

RequerenteTk Hitech Technology Co., Ltd.
Data da decisão2021-04-16
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

BIOTECH Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Tk Hitech Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-04-16 under 510(k) number K202419. 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 BIOTECH Nitrile Examination Gloves?

BIOTECH Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-04-16. The listed applicant is Tk Hitech Technology Co., Ltd.. The 510(k) number is K202419.

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

BIOTECH Nitrile Examination Gloves received FDA 510(k) clearance on 2021-04-16, under 510(k) number K202419.

Who is the listed applicant for BIOTECH Nitrile Examination Gloves?

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

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

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

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Dispositivos Relacionados (Código: LZA)

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Fonte oficial

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