Cleared Traditional

K945833 - ELASTYREN(R) SURGICAL GLOVES

K945833 is an FDA 510(k) clearance for ELASTYREN SURGICAL GLOVES, manufactured by Eci Medical Technologies, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K945833 · Eci Medical Technologies, Inc. · General Hospital
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Jan 1995
Decision
49d
Days
Class 1
Risk

K945833 is an FDA 510(k) clearance for the ELASTYREN(R) SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Eci Medical Technologies, Inc. (Richmondhill, Ontario, CA). The FDA issued a Cleared decision on January 17, 1995 after a review of 49 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 Eci Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K945833

510(k) Number K945833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1994
Decision Date January 17, 1995
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 283
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K945833.
MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GLOVES
K945157 · Johnson & Johnson Medical, Inc. · Feb 1995
MICRO-TOUCH LP LATEX SURGICAL GLOVES
K945158 · Johnson & Johnson Medical, Inc. · Feb 1995
ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED)
K943566 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES
K941770 · Baxter Healthcare Corp · Jul 1994
SURESOFT SURGICAL GLOVES
K940218 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
COMFIT
K935464 · Wembley Rubber Products (M) Sdn Bhd · May 1994