FDA 510(k)

Disposable Medical Face Mask

Número K: K211833 · 2022-01-16

RequerenteZhejiang the Purples Protective Products Co.,Ltd

Data da decisão2022-01-16

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang the Purples Protective Products Co.,Ltd. It received FDA 510(k) clearance on 2022-01-16 under 510(k) number K211833. 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 Medical Face Mask?

Disposable Medical Face Mask is a medical device that received FDA 510(k) clearance on 2022-01-16. The listed applicant is Zhejiang the Purples Protective Products Co.,Ltd. The 510(k) number is K211833.

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

Disposable Medical Face Mask received FDA 510(k) clearance on 2022-01-16, under 510(k) number K211833.

Who is the listed applicant for Disposable Medical Face Mask?

The FDA 510(k) record lists Zhejiang the Purples Protective Products Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

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

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

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