Cleared Traditional

K954325 - NEOLON NEOPRENE SURGICAL GLOVES

K954325 is an FDA 510(k) clearance for NEOLON NEOPRENE 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 242-day FDA review.

K954325 · Maxxim Medical · General Hospital
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May 1996
Decision
242d
Days
Class 1
Risk

K954325 is an FDA 510(k) clearance for the NEOLON NEOPRENE SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Maxxim Medical (Clearwater, US). The FDA issued a Cleared decision on May 14, 1996 after a review of 242 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 - K954325

510(k) Number K954325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date May 14, 1996
Days to Decision 242 days
Submission Type Traditional
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
113d slower than avg
Panel avg: 129d · This submission: 242d
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 K954325.
DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES
K962813 · Maxxim Medical · Jan 1997
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
K962986 · Johnson & Johnson Medical, Inc. · Sep 1996
MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES
K961632 · Johnson & Johnson Medical, Inc. · Jul 1996
COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
K960178 · Wembley Rubber Products (M) Sdn Bhd · May 1996
COMFIT ORTHOPEDIC
K960407 · Wembley Rubber Products (M) Sdn Bhd · Apr 1996
COMFIT MICROPTIC
K960416 · Wembley Rubber Products (M) Sdn Bhd · Apr 1996