FDA 510(k)

Penta Glove

Número K: K212847 · 2022-01-06

Data da decisão2022-01-06

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Penta Glove is the device name listed in this FDA 510(k) record. The listed applicant is Pentavest Holdings Sdn Bhd. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K212847. 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 Penta Glove?

Penta Glove is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Pentavest Holdings Sdn Bhd. The 510(k) number is K212847.

When did Penta Glove receive FDA 510(k) clearance?

Penta Glove received FDA 510(k) clearance on 2022-01-06, under 510(k) number K212847.

Who is the listed applicant for Penta Glove?

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

What is the FDA product code for Penta Glove?

The FDA product code for Penta Glove is LZA.

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