Cleared Traditional

K113707 - STERILE NEOPRENE POWDER-FREE SURGICAL G...

K113707 is an FDA 510(k) clearance for STERILE NEOPRENE POWDER-FREE SURGICAL G..., manufactured by Cardinal Health-Medical Products and Services. 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.

K113707 · Cardinal Health-Medical Products and Services · General Hospital
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Apr 2012
Decision
133d
Days
Class 1
Risk

K113707 is an FDA 510(k) clearance for the STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinal Health-Medical Products and Services (Waukegan, US). The FDA issued a Cleared decision on April 27, 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.

View all Cardinal Health-Medical Products and Services devices

FDA 510(k) Submission Details - K113707

510(k) Number K113707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2011
Decision Date April 27, 2012
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 258
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K113707.
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · Molnlycke Health Care Us, LLC · Sep 2014
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
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K113233 · Shen Wei (Usa), Inc. · Mar 2012
BIOGEL (R) INDICATOR (R) UNDERGLOVE
K111413 · Molnlycke Health Care Us, LLC · Jan 2012
NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
K110698 · Terang Nusa Sdn Bhd · Dec 2011