FDA 510(k)

Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)

Número K: K182612 · 2019-05-10

Data da decisão2019-05-10

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Yahao Supplies Co., Ltd.. It received FDA 510(k) clearance on 2019-05-10 under 510(k) number K182612. 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 Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)?

Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) is a medical device that received FDA 510(k) clearance on 2019-05-10. The listed applicant is Zibo Yahao Supplies Co., Ltd.. The 510(k) number is K182612.

When did Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) received FDA 510(k) clearance on 2019-05-10, under 510(k) number K182612.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)?

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

What is the FDA product code for Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)?

The FDA product code for Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) is LZA.

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