FDA 510(k)

Zoupure Nitrile Powder Free Examination glove

Número K: K220693 · 2022-06-07

RequerenteThai Rayong Product Glove Zoupure Co., Ltd.

Data da decisão2022-06-07

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Zoupure Nitrile Powder Free Examination glove is the device name listed in this FDA 510(k) record. The listed applicant is Thai Rayong Product Glove Zoupure Co., Ltd.. It received FDA 510(k) clearance on 2022-06-07 under 510(k) number K220693. 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 Zoupure Nitrile Powder Free Examination glove?

Zoupure Nitrile Powder Free Examination glove is a medical device that received FDA 510(k) clearance on 2022-06-07. The listed applicant is Thai Rayong Product Glove Zoupure Co., Ltd.. The 510(k) number is K220693.

When did Zoupure Nitrile Powder Free Examination glove receive FDA 510(k) clearance?

Zoupure Nitrile Powder Free Examination glove received FDA 510(k) clearance on 2022-06-07, under 510(k) number K220693.

Who is the listed applicant for Zoupure Nitrile Powder Free Examination glove?

The FDA 510(k) record lists Thai Rayong Product Glove Zoupure Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zoupure Nitrile Powder Free Examination glove?

The FDA product code for Zoupure Nitrile Powder Free Examination glove is LZA.

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