Cleared Abbreviated

Sterile Powder Free Synthetic Rubber Surgeon?s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

K250313 · Harps Europe Manufacturing GmbH · General Hospital

Aug 2025

Decision

197d

Days

Class 1

Risk

About This 510(k) Submission

K250313 is an FDA 510(k) clearance for the Sterile Powder Free Synthetic Rubber Surgeon?s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Harps Europe Manufacturing GmbH (Niederosterreich, AT). The FDA issued a Cleared decision on August 19, 2025, 197 days after receiving the submission on February 3, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K250313 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2025
Decision Date	August 19, 2025
Days to Decision	197 days
Submission Type	Abbreviated
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.