FDA 510(k)

Polyisoprene Surgical gloves

Número K: K240790 · 2024-08-23

RequerenteSuzhou Colour-Way New Material Co., Ltd.

Data da decisão2024-08-23

Código do produtoKGO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Polyisoprene Surgical gloves is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Colour-Way New Material Co., Ltd.. It received FDA 510(k) clearance on 2024-08-23 under 510(k) number K240790. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Polyisoprene Surgical gloves?

Polyisoprene Surgical gloves is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is Suzhou Colour-Way New Material Co., Ltd.. The 510(k) number is K240790.

When did Polyisoprene Surgical gloves receive FDA 510(k) clearance?

Polyisoprene Surgical gloves received FDA 510(k) clearance on 2024-08-23, under 510(k) number K240790.

Who is the listed applicant for Polyisoprene Surgical gloves?

The FDA 510(k) record lists Suzhou Colour-Way New Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polyisoprene Surgical gloves?

The FDA product code for Polyisoprene Surgical gloves is KGO.

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