Cleared Traditional

K943674 - NEUTRALON LP BROWN LATEX SURGICAL GLOVES

K943674 is an FDA 510(k) clearance for NEUTRALON LP BROWN LATEX SURGICAL GLOVES, manufactured by Maxxim Medical. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K943674 · Maxxim Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
202d
Days
Class 1
Risk

K943674 is an FDA 510(k) clearance for the NEUTRALON LP BROWN LATEX SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Maxxim Medical (Arlington, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 202 days - an extended review 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: 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 Maxxim Medical devices

FDA 510(k) Submission Details - K943674

510(k) Number K943674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1994
Decision Date February 13, 1995
Days to Decision 202 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
73d slower than avg
Panel avg: 129d · This submission: 202d
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 241
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K943674.
COMFIT/BEADED SURGEON'S GLOVE
K951662 · Wembley Rubber Products (M) Sdn Bhd · May 1995
SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED)
K943254 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995
SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED)
K943255 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995
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