FDA 510(k)

Thermoplastic Elastomer (TPE) Hybrid Examination Glove

N.º K: K210463 · 2022-01-23

SolicitanteXuzhou Full Sun Medical Products , Ltd.

Fecha de decisión2022-01-23

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Thermoplastic Elastomer (TPE) Hybrid Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Full Sun Medical Products , Ltd.. It received FDA 510(k) clearance on 2022-01-23 under 510(k) number K210463. 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 Thermoplastic Elastomer (TPE) Hybrid Examination Glove?

Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a medical device that received FDA 510(k) clearance on 2022-01-23. The listed applicant is Xuzhou Full Sun Medical Products , Ltd.. The 510(k) number is K210463.

When did Thermoplastic Elastomer (TPE) Hybrid Examination Glove receive FDA 510(k) clearance?

Thermoplastic Elastomer (TPE) Hybrid Examination Glove received FDA 510(k) clearance on 2022-01-23, under 510(k) number K210463.

Who is the listed applicant for Thermoplastic Elastomer (TPE) Hybrid Examination Glove?

The FDA 510(k) record lists Xuzhou Full Sun Medical Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermoplastic Elastomer (TPE) Hybrid Examination Glove?

The FDA product code for Thermoplastic Elastomer (TPE) Hybrid Examination Glove is LZA.

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Fuente oficial

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