FDA 510(k)

Disposable Medical Surgical Face Masks

Número K: K202211 · 2020-12-22

RequerenteGuangdong Kaidi Garments Co.,Ltd

Data da decisão2020-12-22

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Medical Surgical Face Masks is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kaidi Garments Co.,Ltd. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K202211. 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 Surgical Face Masks?

Disposable Medical Surgical Face Masks is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Guangdong Kaidi Garments Co.,Ltd. The 510(k) number is K202211.

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

Disposable Medical Surgical Face Masks received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202211.

Who is the listed applicant for Disposable Medical Surgical Face Masks?

The FDA 510(k) record lists Guangdong Kaidi Garments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Surgical Face Masks?

The FDA product code for Disposable Medical Surgical Face Masks is FXX.

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