FDA 510(k)

Disposable Medical Face Mask (ear loop)

Número K: K221196 · 2022-07-22

RequerenteXiantao Topmed Nonwoven Protective Products Co., Ltd.

Data da decisão2022-07-22

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Medical Face Mask (ear loop) is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Topmed Nonwoven Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K221196. 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 (ear loop)?

Disposable Medical Face Mask (ear loop) is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Xiantao Topmed Nonwoven Protective Products Co., Ltd.. The 510(k) number is K221196.

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

Disposable Medical Face Mask (ear loop) received FDA 510(k) clearance on 2022-07-22, under 510(k) number K221196.

Who is the listed applicant for Disposable Medical Face Mask (ear loop)?

The FDA 510(k) record lists Xiantao Topmed Nonwoven 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 (ear loop)?

The FDA product code for Disposable Medical Face Mask (ear loop) is FXX.

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Outros registros que listam Xiantao Topmed Nonwoven Protective Products Co., Ltd. como candidato(a)

K221977Disposable Surgical Gown (G4003)

Dispositivos Relacionados (Código: FXX)

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Fonte oficial

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