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FDA 510(k)

Sterilized Latex Surgical Gloves

K-Number: K222620 · 2023-03-23

ApplicantSuzhou Colour-Way New Material Co., Ltd.
Decision Date2023-03-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterilized Latex Surgical Gloves is a medical device manufactured by Suzhou Colour-Way New Material Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under approval number K222620. 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 Sterilized Latex Surgical Gloves?

Sterilized Latex Surgical Gloves is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Suzhou Colour-Way New Material Co., Ltd.. The 510(k) number is K222620.

When was Sterilized Latex Surgical Gloves approved by the FDA?

Sterilized Latex Surgical Gloves received FDA 510(k) clearance on 2023-03-23, under approval number K222620.

What company makes Sterilized Latex Surgical Gloves?

Sterilized Latex Surgical Gloves is manufactured by Suzhou Colour-Way New Material Co., Ltd..

What is the FDA product code for Sterilized Latex Surgical Gloves?

The FDA product code for Sterilized Latex Surgical Gloves is KGO.

Related Clinical Trials

NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT06828250 Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD) COMPLETED

Other Devices by Suzhou Colour-Way New Material Co., Ltd.

K222611Male Latex Condoms K240790Polyisoprene Surgical gloves

Related Devices (Code: KGO)

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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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