FDA 510(k)

Stronghold Group Nitrile Examination Glove, Powder Free

Número K: K213859 · 2022-01-13

Data da decisão2022-01-13

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stronghold Group Nitrile Examination Glove, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Stronghold Group, LLC. It received FDA 510(k) clearance on 2022-01-13 under 510(k) number K213859. 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 Stronghold Group Nitrile Examination Glove, Powder Free?

Stronghold Group Nitrile Examination Glove, Powder Free is a medical device that received FDA 510(k) clearance on 2022-01-13. The listed applicant is Stronghold Group, LLC. The 510(k) number is K213859.

When did Stronghold Group Nitrile Examination Glove, Powder Free receive FDA 510(k) clearance?

Stronghold Group Nitrile Examination Glove, Powder Free received FDA 510(k) clearance on 2022-01-13, under 510(k) number K213859.

Who is the listed applicant for Stronghold Group Nitrile Examination Glove, Powder Free?

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

What is the FDA product code for Stronghold Group Nitrile Examination Glove, Powder Free?

The FDA product code for Stronghold Group Nitrile Examination Glove, Powder Free is LZA.

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