FDA 510(k)

O'Star Nitrile Examination Gloves Powder Free

Número K: K213058 · 2022-02-08

RequerenteStar Investment and Trade Joint Stock Company

Data da decisão2022-02-08

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

O'Star Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Star Investment and Trade Joint Stock Company. It received FDA 510(k) clearance on 2022-02-08 under 510(k) number K213058. 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 O'Star Nitrile Examination Gloves Powder Free?

O'Star Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2022-02-08. The listed applicant is Star Investment and Trade Joint Stock Company. The 510(k) number is K213058.

When did O'Star Nitrile Examination Gloves Powder Free receive FDA 510(k) clearance?

O'Star Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2022-02-08, under 510(k) number K213058.

Who is the listed applicant for O'Star Nitrile Examination Gloves Powder Free?

The FDA 510(k) record lists Star Investment and Trade Joint Stock Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O'Star Nitrile Examination Gloves Powder Free?

The FDA product code for O'Star Nitrile Examination Gloves Powder Free is LZA.

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