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FDA 510(k)

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

N.º K: K211667 · 2021-09-23

SolicitanteChangzhou Universal Medical Equipment Co., Ltd.
Fecha de decisión2021-09-23
Código de productoLAZ
Comité asesorTX
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K211667. The device is classified under product code LAZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. The 510(k) number is K211667.

When did Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) receive FDA 510(k) clearance?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211667.

Who is the listed applicant for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

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

What is the FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

The FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is LAZ.

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Otros registros que enlistan a Changzhou Universal Medical Equipment Co., Ltd. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K213910Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy DrugsK210145Nitrile Glove Powder Free Blue

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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