Cleared Traditional

Single-Use Latex Sterile Surgical Gloves (SG100)

K231446 · Fitone Latex Products Co., Ltd. Guangdong · General Hospital

Sep 2023

Decision

127d

Days

Class 1

Risk

About This 510(k) Submission

K231446 is an FDA 510(k) clearance for the Single-Use Latex Sterile Surgical Gloves (SG100), a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Fitone Latex Products Co., Ltd. Guangdong (Zhanjiang, CN). The FDA issued a Cleared decision on September 22, 2023, 127 days after receiving the submission on May 18, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K231446 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2023
Decision Date	September 22, 2023
Days to Decision	127 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.