Cleared Traditional

K945157 - MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GL...

K945157 is the FDA 510(k) clearance for MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GL... by Johnson & Johnson Medical, Inc.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K945157 · Johnson & Johnson Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
115d
Days
Class 1
Risk

K945157 is an FDA 510(k) clearance for the MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 115 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number K945157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1994
Decision Date February 13, 1995
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K945157.
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
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
DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES
K941770 · Baxter Healthcare Corp · Jul 1994