Cleared Special

K111413 - BIOGEL (R) INDICATOR (R) UNDERGLOVE

K111413 is an FDA 510(k) clearance for BIOGEL INDICATOR UNDERGLOVE, manufactured by Molnlycke Health Care Us, LLC. The device is a Class 1 General Hospital device with product code KGO cleared through the Special 510(k) pathway after a 255-day FDA review.

K111413 · Molnlycke Health Care Us, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
255d
Days
Class 1
Risk

K111413 is an FDA 510(k) clearance for the BIOGEL (R) INDICATOR (R) UNDERGLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Molnlycke Health Care Us, LLC (Norcross, US). The FDA issued a Cleared decision on January 30, 2012 after a review of 255 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. 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. Standard predicate reliance. 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 - K111413

510(k) Number K111413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2011
Decision Date January 30, 2012
Days to Decision 255 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
126d slower than avg
Panel avg: 129d · This submission: 255d
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 548
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K111413.
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K113707 · Cardinal Health-Medical Products and Services · Apr 2012
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K113233 · Shen Wei (Usa), Inc. · Mar 2012
POWDERFREE POLYISOPRENE SURGICAL GLOVES
K112654 · Pt. Medisafe Technologies · Feb 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
STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
K111868 · Cardinal Health-Medical Products and Services · Sep 2011
K111413 · BIOGEL (R) INDICATOR (R) UNDERGLOVE
Download PDF FDA Summary Molnlycke Health Care…