Cleared Special

K141719 - BIOGEL PL MICRO SURGICAL GLOVE

K141719 is an FDA 510(k) clearance for BIOGEL PL MICRO SURGICAL GLOVE, 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 71-day FDA review.

K141719 · Molnlycke Health Care Us, LLC · General Hospital
Download Printable Device Report (PDF)
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Sep 2014
Decision
71d
Days
Class 1
Risk

K141719 is an FDA 510(k) clearance for the BIOGEL PL MICRO SURGICAL GLOVE. 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 4, 2014 after a review of 71 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.

View all Molnlycke Health Care Us, LLC devices

FDA 510(k) Submission Details - K141719

510(k) Number K141719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2014
Decision Date September 04, 2014
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 322
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K141719.
Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs
K142190 · Pt. Medisafe Technologies · Jul 2015
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
K140477 · Molnlycke Health Care Us, LLC · Mar 2015
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
K140355 · Terang Nusa Sdn Bhd · Nov 2014
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
K121897 · Cardinal Health, Inc. · Jul 2012
PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
K120934 · Cardinal Health, Inc. · May 2012
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K113707 · Cardinal Health-Medical Products and Services · Apr 2012