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FDA 510(k)

Vinyl Patient Examination Gloves

N.º K: K211239 · 2021-07-17

SolicitanteJiangxi Shengda Medical Technology Co., Ltd.
Fecha de decisión2021-07-17
Código de productoLYZ
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Vinyl Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Shengda Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-17 under 510(k) number K211239. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vinyl Patient Examination Gloves?

Vinyl Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-07-17. The listed applicant is Jiangxi Shengda Medical Technology Co., Ltd.. The 510(k) number is K211239.

When did Vinyl Patient Examination Gloves receive FDA 510(k) clearance?

Vinyl Patient Examination Gloves received FDA 510(k) clearance on 2021-07-17, under 510(k) number K211239.

Who is the listed applicant for Vinyl Patient Examination Gloves?

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

What is the FDA product code for Vinyl Patient Examination Gloves?

The FDA product code for Vinyl Patient Examination Gloves is LYZ.

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Dispositivos relacionados (Código: LYZ)

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.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Fuente oficial

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