FDA 510(k)

Edma Synthetic Nitrile Examination Gloves

Número K: K211540 · 2021-08-09

Data da decisão2021-08-09

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Edma Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Edma Group, LLC. It received FDA 510(k) clearance on 2021-08-09 under 510(k) number K211540. 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 Edma Synthetic Nitrile Examination Gloves?

Edma Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-08-09. The listed applicant is Edma Group, LLC. The 510(k) number is K211540.

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

Edma Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-08-09, under 510(k) number K211540.

Who is the listed applicant for Edma Synthetic Nitrile Examination Gloves?

The FDA 510(k) record lists Edma Group, LLC as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Edma Synthetic Nitrile Examination Gloves is LZA.

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Outros registros que listam Edma Group, LLC como candidato(a)

K211547Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

Dispositivos Relacionados (Código: LZA)

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