Cleared Traditional

K983240 - NEUTRALON PF POWDER FREE BROWN LATEX SU...

K983240 is the FDA 510(k) clearance for NEUTRALON PF POWDER FREE BROWN LATEX SU... by Johnson & Johnson Medical, Div. of Ethicon, Inc.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K983240 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
76d
Days
Class 1
Risk

K983240 is an FDA 510(k) clearance for the NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Johnson & Johnson Medical, Div. of Ethicon, Inc. (Arlington, US). The FDA issued a Cleared decision on November 30, 1998 after a review of 76 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 Johnson & Johnson Medical, Div. of Ethicon, Inc. devices

Submission Details

510(k) Number K983240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1998
Decision Date November 30, 1998
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 165
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K983240.
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K992171 · Allegiance Healthcare Corp. · Sep 1999
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
K991992 · Allegiance Healthcare Corp. · Jul 1999
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
K982600 · Wembley Rubber Products (M) Sdn Bhd · Mar 1999
ULTRALON POWDER FREE LATEX SURGICAL GLOVE
K973699 · Johnson & Johnson Medical, Inc. · Dec 1997
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
K972621 · Wembley Rubber Products (M) Sdn Bhd · Oct 1997
POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES
K971381 · Allegiance Healthcare Corp. · Jul 1997