Cleared Traditional

K153316 - Cardinal Health Sterile Neoprene Powder...

K153316 is an FDA 510(k) clearance for Cardinal Health Sterile Neoprene Powder..., manufactured by Cardinal Health, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K153316 · Cardinal Health, Inc. · General Hospital
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May 2016
Decision
177d
Days
Class 1
Risk

K153316 is an FDA 510(k) clearance for the Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coa.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinal Health, Inc. (Waukegan, US). The FDA issued a Cleared decision on May 12, 2016 after a review of 177 days - an extended review cycle.

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, Inc. devices

FDA 510(k) Submission Details - K153316

510(k) Number K153316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2015
Decision Date May 12, 2016
Days to Decision 177 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 129d · This submission: 177d
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 189
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K153316.
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
K170152 · Hartalega Sdn Bhd · May 2017
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
K161823 · Wrp Asia Pacific Sdn. Bhd. · Jan 2017
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
K161008 · Hartalega Sdn Bhd · Jul 2016
SensiCare PI Surgical Gloves
K152428 · Medline Industries, Inc. · Mar 2016
SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color
K150238 · Medline Industries, Inc. · Nov 2015
Biogel PI Micro Indicator Underglove
K150146 · Molnlycke Health Care Us, LLC · Aug 2015