FDA 510(k)

Black Pearl Nitrile Examination Glove

Número K: K232319 · 2024-04-22

Data da decisão2024-04-22

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Black Pearl Nitrile Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Ug Global Resources Sdn. Bhd.. It received FDA 510(k) clearance on 2024-04-22 under 510(k) number K232319. 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 Black Pearl Nitrile Examination Glove?

Black Pearl Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2024-04-22. The listed applicant is Ug Global Resources Sdn. Bhd.. The 510(k) number is K232319.

When did Black Pearl Nitrile Examination Glove receive FDA 510(k) clearance?

Black Pearl Nitrile Examination Glove received FDA 510(k) clearance on 2024-04-22, under 510(k) number K232319.

Who is the listed applicant for Black Pearl Nitrile Examination Glove?

The FDA 510(k) record lists Ug Global Resources Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Black Pearl Nitrile Examination Glove?

The FDA product code for Black Pearl Nitrile Examination Glove is LZA.

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Outros registros que listam Ug Global Resources Sdn. Bhd. como candidato(a)

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