Cleared Traditional

K111868 - STERILE POLYISOPRENE POWDER-FREE BLUE S...

K111868 is an FDA 510(k) clearance for STERILE POLYISOPRENE POWDER-FREE BLUE S..., 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 82-day FDA review.

K111868 · Cardinal Health-Medical Products and Services · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
82d
Days
Class 1
Risk

K111868 is an FDA 510(k) clearance for the STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIEN.... 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 September 21, 2011 after a review of 82 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardinal Health-Medical Products and Services devices

FDA 510(k) Submission Details - K111868

510(k) Number K111868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2011
Decision Date September 21, 2011
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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 258
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K111868.
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
PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
K111878 · Cardinal Health, Inc. · Sep 2011
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
K112257 · Molnlycke Health Care Us, LLC · Sep 2011
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
K112089 · Molnlycke Health Care Us, LLC · Aug 2011
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
K111807 · Medline Industries, Inc. · Aug 2011