Cleared Special

K053272 - CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES

K053272 is an FDA 510(k) clearance for CARDINAL HEALTH PROTEGRITY BLUE WITH NE..., manufactured by Cardinalhealth. The device is a Class 1 General Hospital device with product code KGO cleared through the Special 510(k) pathway after a 43-day FDA review.

K053272 · Cardinalhealth · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
43d
Days
Class 1
Risk

K053272 is an FDA 510(k) clearance for the CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on January 5, 2006 after a review of 43 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.

FDA 510(k) Submission Details - K053272

510(k) Number K053272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2005
Decision Date January 05, 2006
Days to Decision 43 days
Submission Type Special
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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 558
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K053272.
BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
K053102 · Regent Medical Americas, LLC · Mar 2006
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
K053442 · Regent Medical Americas, LLC · Mar 2006
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
K053443 · Regent Medical Americas, LLC · Feb 2006
BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES
K052772 · Barriermed Glove Co. · Dec 2005
POWDER FREE STERILE LATEX SURGICAL GLOVES
K052177 · Hartalega Sdn Bhd · Dec 2005
SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
K052837 · Terang Nusa Sdn Bhd · Nov 2005
K053272 · CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
Download PDF FDA Summary Cardinalhealth