Cleared Traditional

K053443 - BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE

K053443 is an FDA 510(k) clearance for BIOGEL ECLIPSE NON-PYROGENIC LATEX POWD..., 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 54-day FDA review.

K053443 · Regent Medical Americas, LLC · General Hospital
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Feb 2006
Decision
54d
Days
Class 1
Risk

K053443 is an FDA 510(k) clearance for the BIOGEL ECLIPSE NON-PYROGENIC 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 February 1, 2006 after a review of 54 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 - K053443

510(k) Number K053443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2005
Decision Date February 01, 2006
Days to Decision 54 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
75d faster than avg
Panel avg: 129d · This submission: 54d
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 K053443.
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · Zimmer, Inc. · Apr 2007
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
K062950 · Hartalega Sdn Bhd · Dec 2006
BIOGEL ECLIPSE INDICATOR UNDERGLOVE
K062847 · Molnlycke Health Care Us, LLC · Dec 2006
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
K053272 · Cardinalhealth · Jan 2006
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