Cleared Special

K102119 - SUR-G GLOV AND MAXITEX

K102119 is an FDA 510(k) clearance for SUR-G GLOV AND MAXITEX, manufactured by Terang Nusa Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Special 510(k) pathway after a 30-day FDA review.

K102119 · Terang Nusa Sdn Bhd · General Hospital
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Aug 2010
Decision
30d
Days
Class 1
Risk

K102119 is an FDA 510(k) clearance for the SUR-G GLOV AND MAXITEX. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Terang Nusa Sdn Bhd (Kota Bharu, Kelantan, MY). The FDA issued a Cleared decision on August 27, 2010 after a review of 30 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 Terang Nusa Sdn Bhd devices

FDA 510(k) Submission Details - K102119

510(k) Number K102119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2010
Decision Date August 27, 2010
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
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 351
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K102119.
STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
K111015 · Cardinal Health, Inc. · May 2011
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K102500 · Cardinal Health, Inc. · Nov 2010
PROTEGRITY SMT LATEX SURGICALGLOVES
K101811 · Cardinal Health, Inc. · Oct 2010
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES
K093300 · Cardinal Health, Inc. · Oct 2009
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K092304 · Cardinal Health, Inc. · Sep 2009
SKINSENSE POLYISOPRENE UNDERGLOVE
K081180 · Molnlycke Health Care Us, LLC · Aug 2008