Cleared Traditional

K041437 - MAXITEX LATEX NEURO PF SURGICAL GLOVE P...

K041437 is an FDA 510(k) clearance for MAXITEX LATEX NEURO PF SURGICAL GLOVE P..., 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 111-day FDA review.

K041437 · Terang Nusa Sdn Bhd · General Hospital
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Sep 2004
Decision
111d
Days
Class 1
Risk

K041437 is an FDA 510(k) clearance for the MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE. 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 September 16, 2004 after a review of 111 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 - K041437

510(k) Number K041437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2004
Decision Date September 16, 2004
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
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 K041437.
NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE
K051094 · Terang Nusa Sdn Bhd · Jun 2005
DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
K043508 · Ansell Healthcare Products, LLC · Jan 2005
ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)
K042574 · Cardinalhealth · Dec 2004
SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2
K041436 · Terang Nusa Sdn Bhd · Aug 2004
PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING
K033905 · Cardinalhealth · Apr 2004
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
K040503 · Wrp Asia Pacific Sdn. Bhd. · Mar 2004