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FDA 510(k)

Synthetic Nitrile Examination Gloves

Número K: K212488 · 2021-11-26

RequerenteShandong Hongxin Chemicals Co., Ltd.
Data da decisão2021-11-26
Código do produtoLYZ
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Hongxin Chemicals Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under 510(k) number K212488. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Synthetic Nitrile Examination Gloves?

Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-11-26. The listed applicant is Shandong Hongxin Chemicals Co., Ltd.. The 510(k) number is K212488.

When did Synthetic Nitrile Examination Gloves receive FDA 510(k) clearance?

Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-11-26, under 510(k) number K212488.

Who is the listed applicant for Synthetic Nitrile Examination Gloves?

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

What is the FDA product code for Synthetic Nitrile Examination Gloves?

The FDA product code for Synthetic Nitrile Examination Gloves is LYZ.

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Dispositivos Relacionados (Código: LYZ)

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