Cleared Traditional

K983240 - NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES

K983240 is an FDA 510(k) clearance for NEUTRALON PF POWDER FREE BROWN LATEX SU..., manufactured by Johnson & Johnson Medical, Div. of Ethicon, Inc.. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K983240

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 353
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K983240.
ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
K983962 · Cardinal Health-Medical Products and Services · Jan 1999
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
K984064 · Omni Intl., Inc. · Jan 1999
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)
K983489 · Ansell Perry · Dec 1998
SEMPERMED SURGEONS' GLOVES - SUPREME
K981096 · Semperit Technische Produkte Gesellshaft · Oct 1998
SURGEON'S GLOVE
K982589 · Shiva Medicare , Ltd. · Sep 1998
OMNI PRO LATEX SURGICAL GLOVE, POWDERED
K982613 · Omnigrace (Thailand) , Ltd. · Sep 1998