FDA 510(k)

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue

N.º K: K162510 · 2017-07-18

SolicitanteUg Global Resources Sdn. Bhd.

Fecha de decisión2017-07-18

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue 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 2017-07-18 under 510(k) number K162510. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue?

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Ug Global Resources Sdn. Bhd.. The 510(k) number is K162510.

When did Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue receive FDA 510(k) clearance?

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue received FDA 510(k) clearance on 2017-07-18, under 510(k) number K162510.

Who is the listed applicant for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue?

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 Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue?

The FDA product code for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is LZA.

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Otros registros que enlistan a Ug Global Resources Sdn. Bhd. como solicitante

K232319Black Pearl Nitrile Examination Glove K161961UniTex Non-Sterile, Powder-Free, Latex Examination Glove

Dispositivos relacionados (Código: LZA)

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Fuente oficial

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