FDA 510(k)

Examination gloves -Type C (Nitrile gloves)

N.º K: K212290 · 2021-10-28

SolicitanteJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

Fecha de decisión2021-10-28

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Examination gloves -Type C (Nitrile gloves) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K212290. 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 Examination gloves -Type C (Nitrile gloves)?

Examination gloves -Type C (Nitrile gloves) is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. The 510(k) number is K212290.

When did Examination gloves -Type C (Nitrile gloves) receive FDA 510(k) clearance?

Examination gloves -Type C (Nitrile gloves) received FDA 510(k) clearance on 2021-10-28, under 510(k) number K212290.

Who is the listed applicant for Examination gloves -Type C (Nitrile gloves)?

The FDA 510(k) record lists Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Examination gloves -Type C (Nitrile gloves)?

The FDA product code for Examination gloves -Type C (Nitrile gloves) is LZA.

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Otros registros que enlistan a Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. como solicitante

K214017Examination gloves-Type A(Latex gloves)K211953Disposable Sterilized Latex Surgical Gloves

Dispositivos relacionados (Código: LZA)

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Fuente oficial

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