Cleared Traditional

K071414 - BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K071414 is an FDA 510(k) clearance for BIOGEL ECLIPSE, 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 112-day FDA review.

K071414 · Molnlycke Health Care Us, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 2007
Decision
112d
Days
Class 1
Risk

K071414 is an FDA 510(k) clearance for the BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT.... 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 September 10, 2007 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Molnlycke Health Care Us, LLC devices

FDA 510(k) Submission Details - K071414

510(k) Number K071414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date September 10, 2007
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 323
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K071414.
DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
K071746 · Ansell Healthcare Products, LLC · Dec 2007
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
K071465 · Molnlycke Health Care Us, LLC · Sep 2007
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
K071700 · Molnlycke Health Care Us, LLC · Sep 2007
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
K071565 · Molnlycke Health Care Us, LLC · Sep 2007
POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING
K070619 · Wrp Asia Pacific Sdn. Bhd. · Jun 2007
TRIFLEX SELECT
K070647 · Cardinal Health, Inc. · Jun 2007