Cleared Traditional

K062847 - BIOGEL ECLIPSE INDICATOR UNDERGLOVE

K062847 is an FDA 510(k) clearance for BIOGEL ECLIPSE 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 Traditional 510(k) pathway after a 77-day FDA review.

K062847 · 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
Dec 2006
Decision
77d
Days
Class 1
Risk

K062847 is an FDA 510(k) clearance for the BIOGEL ECLIPSE INDICATOR 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 December 20, 2006 after a review of 77 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.

FDA 510(k) Submission Details - K062847

510(k) Number K062847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2006
Decision Date December 20, 2006
Days to Decision 77 days
Submission Type Traditional
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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 549
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K062847.
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · Zimmer, Inc. · Apr 2007
POWDERED LATEX SURGICAL GLOVE
K062797 · Beijing Reagent Latex Products Co., Ltd. · Apr 2007
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
K062950 · Hartalega Sdn Bhd · Dec 2006
BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
K053406 · Barriermed Glove Co. · Jul 2006
THE DOUBLE GLOVE
K060030 · Biobarrier, Inc. · Jun 2006
BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490
K061038 · Barriermed Glove Co. · Jun 2006
K062847 · BIOGEL ECLIPSE INDICATOR UNDERGLOVE
Download PDF FDA Summary Molnlycke Health Care…