FDA 510(k)

Nitrile Patient Examination gloves, Powderfree, Blue color

Número K: K143477 · 2016-04-14

Data da decisão2016-04-14

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Patient Examination gloves, Powderfree, Blue color is the device name listed in this FDA 510(k) record. The listed applicant is Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2016-04-14 under 510(k) number K143477. 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 Nitrile Patient Examination gloves, Powderfree, Blue color?

Nitrile Patient Examination gloves, Powderfree, Blue color is a medical device that received FDA 510(k) clearance on 2016-04-14. The listed applicant is Primus Gloves Pvt Limited. The 510(k) number is K143477.

When did Nitrile Patient Examination gloves, Powderfree, Blue color receive FDA 510(k) clearance?

Nitrile Patient Examination gloves, Powderfree, Blue color received FDA 510(k) clearance on 2016-04-14, under 510(k) number K143477.

Who is the listed applicant for Nitrile Patient Examination gloves, Powderfree, Blue color?

The FDA 510(k) record lists Primus Gloves Pvt Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color?

The FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color is LZA.

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Outros registros que listam Primus Gloves Pvt Limited como candidato(a)

K170612STERILE VINYL EXAMINATION GLOVES, Powder Free K170515Sterile Nitrile Surgical Gloves, Powder-free

Dispositivos Relacionados (Código: LZA)

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