FDA 510(k)

Disposable Medical Face Mask

Número K: K220487 · 2022-04-26

RequerenteHubei Mediunion Medical Products Co., Ltd.

Data da decisão2022-04-26

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 Hubei Mediunion Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-04-26 under 510(k) number K220487. 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 2022-04-26. The listed applicant is Hubei Mediunion Medical Products Co., Ltd.. The 510(k) number is K220487.

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

Disposable Medical Face Mask received FDA 510(k) clearance on 2022-04-26, under 510(k) number K220487.

Who is the listed applicant for Disposable Medical Face Mask?

The FDA 510(k) record lists Hubei Mediunion Medical 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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