Cleared Traditional

K051793 - ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)

K051793 is an FDA 510(k) clearance for ENCORE STERILE POWDER-FREE LATEX SURGIC..., manufactured by Ansell Healthcare Products, LLC. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K051793 · Ansell Healthcare Products, LLC · General Hospital
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Aug 2005
Decision
47d
Days
Class 1
Risk

K051793 is an FDA 510(k) clearance for the ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CON.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ansell Healthcare Products, LLC (Dothan, US). The FDA issued a Cleared decision on August 17, 2005 after a review of 47 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ansell Healthcare Products, LLC devices

FDA 510(k) Submission Details - K051793

510(k) Number K051793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2005
Decision Date August 17, 2005
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 351
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K051793.
POWDER FREE STERILE LATEX SURGICAL GLOVES
K052177 · Hartalega Sdn Bhd · Dec 2005
SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
K052837 · Terang Nusa Sdn Bhd · Nov 2005
NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR
K051562 · Terang Nusa Sdn Bhd · Oct 2005
BIOGEL LATEX STERILE POWDER-FREE GLOVE
K050899 · Regent Medical Americas, LLC · Aug 2005
NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED
K051563 · Terang Nusa Sdn Bhd · Jun 2005
NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE
K051094 · Terang Nusa Sdn Bhd · Jun 2005