Cleared Traditional

Polyisoprene Surgical gloves

K240790 · Suzhou Colour-Way New Material Co., Ltd. · General Hospital

Aug 2024

Decision

154d

Days

Class 1

Risk

About This 510(k) Submission

K240790 is an FDA 510(k) clearance for the Polyisoprene Surgical gloves, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Suzhou Colour-Way New Material Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on August 23, 2024, 154 days after receiving the submission on March 22, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K240790 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2024
Decision Date	August 23, 2024
Days to Decision	154 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	KGO — Surgeon's Gloves
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4460
Definition	A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.