Polyisoprene Surgical gloves— 510(k) K240790

Name: FDA 510(k) clearance K240790
Creator: U.S. Food and Drug Administration
Published: 2024-08-23

Substantially Equivalent

Suzhou Colour-Way New Material Co., Ltd.

FDA 510(k) clearance K240790 for Polyisoprene Surgical gloves, Substantially Equivalent on 2024-08-23. Applicant: Suzhou Colour-Way New Material Co., Ltd.. Device class: 1.

Clearance details

Applicant: Suzhou Colour-Way New Material Co., Ltd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2024-03-22
Decision date: 2024-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.