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FDA 510(k)

Polyisoprene Surgical gloves

K-Number: K240790 · 2024-08-23

ApplicantSuzhou Colour-Way New Material Co., Ltd.
Decision Date2024-08-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Polyisoprene Surgical gloves?

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

When was Polyisoprene Surgical gloves approved by the FDA?

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

What company makes Polyisoprene Surgical gloves?

Polyisoprene Surgical gloves is manufactured by Suzhou Colour-Way New Material Co., Ltd..

What is the FDA product code for Polyisoprene Surgical gloves?

The FDA product code for Polyisoprene Surgical gloves is KGO.

Related Clinical Trials

NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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