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FDA 510(k)

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free

Número K: K212308 · 2021-10-29

RequerenteSrirungruang Global Co., Ltd.
Data da decisão2021-10-29
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Srirungruang Global Co., Ltd.. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K212308. 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 SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free?

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Srirungruang Global Co., Ltd.. The 510(k) number is K212308.

When did SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free receive FDA 510(k) clearance?

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2021-10-29, under 510(k) number K212308.

Who is the listed applicant for SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free?

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

What is the FDA product code for SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free?

The FDA product code for SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free is LZA.

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