Cleared Traditional

GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)

K231902 · Ansell Healthcare · General Hospital

Oct 2023

Decision

114d

Days

Class 1

Risk

About This 510(k) Submission

K231902 is an FDA 510(k) clearance for the GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090), a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Ansell Healthcare (Reno, US). The FDA issued a Cleared decision on October 20, 2023, 114 days after receiving the submission on June 28, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K231902 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2023
Decision Date	October 20, 2023
Days to Decision	114 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.