Cleared Traditional

K000178 - NUZONE NITRILE SURGICAL GLOVES

K000178 is an FDA 510(k) clearance for NUZONE NITRILE SURGICAL GLOVES, manufactured by Terang Nusa Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K000178 · Terang Nusa Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
124d
Days
Class 1
Risk

K000178 is an FDA 510(k) clearance for the NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Terang Nusa Sdn Bhd (Kota Bharu, MY). The FDA issued a Cleared decision on May 23, 2000 after a review of 124 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 Terang Nusa Sdn Bhd devices

FDA 510(k) Submission Details - K000178

510(k) Number K000178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2000
Decision Date May 23, 2000
Days to Decision 124 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
5d faster than avg
Panel avg: 129d · This submission: 124d
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 241
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K000178.
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K002933 · Maxxim Medical · Oct 2000
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K001959 · Hartalega Sdn Bhd · Jul 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
K001924 · Allegiance Healthcare Corp. · Jul 2000
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
K000179 · Terang Nusa Sdn Bhd · May 2000
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · Wrp Asia Pacific Sdn. Bhd. · Apr 2000
SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
K994081 · Safeskin Corp. · Jan 2000