Cleared Traditional

K050533 - ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE

K050533 is an FDA 510(k) clearance for ECLIPSE LATEX POWDER FREE STERILE SURGE..., 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 55-day FDA review.

K050533 · Regent Medical Americas, LLC · General Hospital
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Apr 2005
Decision
55d
Days
Class 1
Risk

K050533 is an FDA 510(k) clearance for the ECLIPSE LATEX POWDER FREE STERILE SURGEON'S 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 April 26, 2005 after a review of 55 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 Regent Medical Americas, LLC devices

FDA 510(k) Submission Details - K050533

510(k) Number K050533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date April 26, 2005
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 K050533.
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
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E
K042567 · Pt. Medisafe Technologies · Jan 2005
ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)
K042574 · Cardinalhealth · Dec 2004