Cleared Special

K021598 - ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE

K021598 is an FDA 510(k) clearance for ELASTYLITE SYNTHETIC POWDERED SURGICAL ..., manufactured by Eci Medical Technologies, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Special 510(k) pathway after a 26-day FDA review.

K021598 · Eci Medical Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
26d
Days
Class 1
Risk

K021598 is an FDA 510(k) clearance for the ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Eci Medical Technologies, Inc. (Bridgewater, Nova Scotia, CA). The FDA issued a Cleared decision on June 10, 2002 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021598

510(k) Number K021598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2002
Decision Date June 10, 2002
Days to Decision 26 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 489
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K021598.
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
K021784 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM
K021119 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
K021159 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
LATEX SURGEONS GLOVE (POWDER FREE)
K014283 · Brightway Gloves Pvt. , Ltd. · May 2002
LATEX SURGEONS GLOVE (POWDERED)
K014278 · Brightway Gloves Pvt. , Ltd. · May 2002
PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
K021065 · Primus Gloves Private , Ltd. · May 2002
K021598 · ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
Download PDF Eci Medical Technolog…