Cleared Traditional

K941770 - DURAPRENE STERILE SYNTHETIC SURGEON'S G...

K941770 is the FDA 510(k) clearance for DURAPRENE STERILE SYNTHETIC SURGEON'S G... by Baxter Healthcare Corp. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K941770 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
85d
Days
Class 1
Risk

K941770 is an FDA 510(k) clearance for the DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on July 5, 1994 after a review of 85 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K941770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1994
Decision Date July 05, 1994
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 180
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K941770.
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
SURESOFT SURGICAL GLOVES
K940218 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
COMFIT
K935464 · Wembley Rubber Products (M) Sdn Bhd · May 1994
MAXXUS ORTHOPAEDIC LATEX SURGICAL GLOVES
K935227 · Johnson & Johnson Medical, Inc. · Mar 1994