Cleared Traditional

K963020 - GLOVEL GX

K963020 is an FDA 510(k) clearance for GLOVEL GX, manufactured by Kenwell International , Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K963020 · Kenwell International , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
114d
Days
Class 1
Risk

K963020 is an FDA 510(k) clearance for the GLOVEL GX. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Kenwell International , Ltd. (Great Neck,, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 114 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 Kenwell International , Ltd. devices

FDA 510(k) Submission Details - K963020

510(k) Number K963020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1996
Decision Date November 27, 1996
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
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 312
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K963020.
SENTURA SURGICAL GLOVES
K964962 · Maxxim Medical · Mar 1997
ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM
K964980 · Maxxim Medical · Mar 1997
DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES
K962813 · Maxxim Medical · Jan 1997
STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED
K962724 · Sonnheim Medikal GmbH · Oct 1996
NULIFE
K962837 · Med-Tech Rubber & Engineering Industries · Oct 1996
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
K962986 · Johnson & Johnson Medical, Inc. · Sep 1996