FDA 510(k)

Nitrile Examination Glove (Powder free, Blue)

N.º K: K212497 · 2021-11-11

SolicitanteJiangsu Jinlian Medical Technology Co., Ltd.

Fecha de decisión2021-11-11

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Examination Glove (Powder free, Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jinlian Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-11 under 510(k) number K212497. 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 Nitrile Examination Glove (Powder free, Blue)?

Nitrile Examination Glove (Powder free, Blue) is a medical device that received FDA 510(k) clearance on 2021-11-11. The listed applicant is Jiangsu Jinlian Medical Technology Co., Ltd.. The 510(k) number is K212497.

When did Nitrile Examination Glove (Powder free, Blue) receive FDA 510(k) clearance?

Nitrile Examination Glove (Powder free, Blue) received FDA 510(k) clearance on 2021-11-11, under 510(k) number K212497.

Who is the listed applicant for Nitrile Examination Glove (Powder free, Blue)?

The FDA 510(k) record lists Jiangsu Jinlian Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Glove (Powder free, Blue)?

The FDA product code for Nitrile Examination Glove (Powder free, Blue) is LZA.

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Dispositivos relacionados (Código: LZA)

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Fuente oficial

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