FDA 510(k)

Biodegradable Medical surgical mask

Número K: K231155 · 2023-11-07

RequerenteGuangdong Kingfa Sci. & Tech.Co., Ltd.

Data da decisão2023-11-07

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biodegradable Medical surgical mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2023-11-07 under 510(k) number K231155. 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 Biodegradable Medical surgical mask?

Biodegradable Medical surgical mask is a medical device that received FDA 510(k) clearance on 2023-11-07. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K231155.

When did Biodegradable Medical surgical mask receive FDA 510(k) clearance?

Biodegradable Medical surgical mask received FDA 510(k) clearance on 2023-11-07, under 510(k) number K231155.

Who is the listed applicant for Biodegradable Medical surgical mask?

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

What is the FDA product code for Biodegradable Medical surgical mask?

The FDA product code for Biodegradable Medical surgical mask is FXX.

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Outros registros que listam Guangdong Kingfa Sci. & Tech.Co., Ltd. como candidato(a)

K233723Medical surgical mask K221983Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color K230046Vinyl examination gloves K222612Powder-Free Latex examination gloves K222714Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs K221887Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color

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Fonte oficial

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