Cleared Traditional

K150973 - NUZONE X2G Polychloroprene Synthetic Gr...

K150973 is an FDA 510(k) clearance for NUZONE X2G Polychloroprene Synthetic Gr..., manufactured by Terang Nusa Snd Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K150973 · Terang Nusa Snd Bhd · General Hospital
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Aug 2015
Decision
113d
Days
Class 1
Risk

K150973 is an FDA 510(k) clearance for the NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Teste.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Terang Nusa Snd Bhd (Kota Bharu, MY). The FDA issued a Cleared decision on August 4, 2015 after a review of 113 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 Snd Bhd devices

FDA 510(k) Submission Details - K150973

510(k) Number K150973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2015
Decision Date August 04, 2015
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
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 275
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K150973.
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
K142941 · Pt. Medisafe Technologies · Nov 2015
Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
K151392 · Terang Nusa Sdn Bhd · Sep 2015
Biogel PI Micro Indicator Underglove
K150146 · Molnlycke Health Care Us, LLC · Aug 2015
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