FDA 510(k)

Disposable Surgical Face Mask

Número K: K203685 · 2021-03-26

RequerenteXiantao Zhongyi Safety & Protection Products Co., Ltd.

Data da decisão2021-03-26

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Zhongyi Safety & Protection Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K203685. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Surgical Face Mask?

Disposable Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Xiantao Zhongyi Safety & Protection Products Co., Ltd.. The 510(k) number is K203685.

When did Disposable Surgical Face Mask receive FDA 510(k) clearance?

Disposable Surgical Face Mask received FDA 510(k) clearance on 2021-03-26, under 510(k) number K203685.

Who is the listed applicant for Disposable Surgical Face Mask?

The FDA 510(k) record lists Xiantao Zhongyi Safety & Protection Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Face Mask?

The FDA product code for Disposable Surgical Face Mask is FXX.

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