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FDA 510(k)

Blue Nitrile Exam Glove, Powder Free

Número K: K210057 · 2021-03-31

RequerenteReal Star Medical Technology Co., Ltd.
Data da decisão2021-03-31
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Blue Nitrile Exam Glove, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Real Star Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K210057. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Blue Nitrile Exam Glove, Powder Free?

Blue Nitrile Exam Glove, Powder Free is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Real Star Medical Technology Co., Ltd.. The 510(k) number is K210057.

When did Blue Nitrile Exam Glove, Powder Free receive FDA 510(k) clearance?

Blue Nitrile Exam Glove, Powder Free received FDA 510(k) clearance on 2021-03-31, under 510(k) number K210057.

Who is the listed applicant for Blue Nitrile Exam Glove, Powder Free?

The FDA 510(k) record lists Real Star Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Nitrile Exam Glove, Powder Free?

The FDA product code for Blue Nitrile Exam Glove, Powder Free is LZA.

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Dispositivos Relacionados (Código: LZA)

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