Cleared Special

PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES (K121897) - FDA 510(k) Clearance

Class I General Hospital device.

K121897 · Cardinal Health, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 97
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K121897.
Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
K172942 · Beta Healthcare Products Pvt., Ltd. · Jan 2018
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
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
K111807 · Medline Industries, Inc. · Aug 2011
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
K102177 · Medline Industries, Inc. · Jun 2011
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · Zimmer, Inc. · Apr 2007