Cleared Special

K121897 - PROTEXIS LATEX BASIC STERILE POWDER-FRE...

K121897 is an FDA 510(k) clearance for PROTEXIS LATEX BASIC STERILE POWDER-FRE..., manufactured by Cardinal Health, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Special 510(k) pathway after a 28-day FDA review.

K121897 · Cardinal Health, Inc. · General Hospital
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Jul 2012
Decision
28d
Days
Class 1
Risk

K121897 is an FDA 510(k) clearance for the PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES. 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 July 27, 2012 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardinal Health, Inc. devices

FDA 510(k) Submission Details - K121897

510(k) Number K121897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2012
Decision Date July 27, 2012
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K121897.
Biogel PI Micro Indicator Underglove
K150146 · Molnlycke Health Care Us, LLC · Aug 2015
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
K140477 · Molnlycke Health Care Us, LLC · Mar 2015
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · Molnlycke Health Care Us, LLC · Sep 2014
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
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
K112257 · Molnlycke Health Care Us, LLC · Sep 2011