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FDA 510(k)

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

Número K: K213144 · 2021-12-22

RequerenteShen Wei USA, Inc.
Data da decisão2021-12-22
Código do produtoLYZ
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and 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 2021-12-22 under 510(k) number K213144. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors?

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K213144.

When did Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors receive FDA 510(k) clearance?

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213144.

Who is the listed applicant for Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and 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 Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors?

The FDA product code for Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors is LYZ.

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Dispositivos Relacionados (Código: LYZ)

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K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Fonte oficial

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