Cleared Traditional

K121335 - G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE

K121335 is an FDA 510(k) clearance for G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE, manufactured by Hutchinson Sante S.N.C.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K121335 · Hutchinson Sante S.N.C. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
133d
Days
Class 1
Risk

K121335 is an FDA 510(k) clearance for the G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Hutchinson Sante S.N.C. (Liancourt, FR). The FDA issued a Cleared decision on September 13, 2012 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K121335

510(k) Number K121335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2012
Decision Date September 13, 2012
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

KGO Device Classification - Class 1, General Controls

Product Code KGO Surgeon's Gloves
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGO Surgeon's Gloves

All 551
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K121335.
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
K130301 · Elimedical Devices (Fujian), Inc. · Aug 2013
FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES
K123629 · Lucenxia Prescience AG · May 2013
STERILE LATEX SURGICAL GLOVE
K123628 · Lucenxia Prescience AG · Mar 2013
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
K121897 · Cardinal Health, Inc. · Jul 2012
PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
K120934 · Cardinal Health, Inc. · May 2012
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K113707 · Cardinal Health-Medical Products and Services · Apr 2012
K121335 · G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
Download PDF FDA Summary Hutchinson Sante S.N.…