Cleared Traditional

Sterilized Latex Surgical Gloves

K222620 · Suzhou Colour-Way New Material Co., Ltd. · General Hospital

Mar 2023

Decision

205d

Days

Class 1

Risk

About This 510(k) Submission

K222620 is an FDA 510(k) clearance for the Sterilized Latex 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 March 23, 2023, 205 days after receiving the submission on August 30, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K222620 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2022
Decision Date	March 23, 2023
Days to Decision	205 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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.