Cleared Traditional

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove

K231973 · Ineo Tech Sdn Bhd · General Hospital

Sep 2023

Decision

88d

Days

Class 1

Risk

About This 510(k) Submission

K231973 is an FDA 510(k) clearance for the PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Ineo Tech Sdn Bhd (Bandar Kassia, MY). The FDA issued a Cleared decision on September 29, 2023, 88 days after receiving the submission on July 3, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K231973 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2023
Decision Date	September 29, 2023
Days to Decision	88 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.