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FDA 510(k)

Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors

Número K: K211455 · 2021-07-28

RequerenteShen Wei USA, Inc.
Data da decisão2021-07-28
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211455. 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 Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors?

Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K211455.

When did Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211455.

Who is the listed applicant for Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors?

The FDA product code for Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors is LZA.

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Fonte oficial

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