Cleared Traditional

K050899 - BIOGEL LATEX STERILE POWDER-FREE GLOVE

K050899 is an FDA 510(k) clearance for BIOGEL LATEX STERILE POWDER-FREE GLOVE, manufactured by Regent Medical Americas, LLC. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K050899 · Regent Medical Americas, LLC · General Hospital
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Aug 2005
Decision
123d
Days
Class 1
Risk

K050899 is an FDA 510(k) clearance for the BIOGEL LATEX STERILE POWDER-FREE GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Regent Medical Americas, LLC (Norcross, US). The FDA issued a Cleared decision on August 12, 2005 after a review of 123 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 Regent Medical Americas, LLC devices

FDA 510(k) Submission Details - K050899

510(k) Number K050899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2005
Decision Date August 12, 2005
Days to Decision 123 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
6d faster than avg
Panel avg: 129d · This submission: 123d
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 322
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K050899.
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
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)
K051793 · Ansell Healthcare Products, 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
DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
K043508 · Ansell Healthcare Products, LLC · Jan 2005