Cleared Traditional

K972009 - PURE ADVANTAGE NITRILE HYPOALLERGENIC S...

K972009 is an FDA 510(k) clearance for PURE ADVANTAGE NITRILE HYPOALLERGENIC S..., manufactured by Tillotson Healthcare Corp.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K972009 · Tillotson Healthcare Corp. · General Hospital
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Sep 1997
Decision
105d
Days
Class 1
Risk

K972009 is an FDA 510(k) clearance for the PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Tillotson Healthcare Corp. (Bedford, US). The FDA issued a Cleared decision on September 12, 1997 after a review of 105 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 Tillotson Healthcare Corp. devices

FDA 510(k) Submission Details - K972009

510(k) Number K972009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date September 12, 1997
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
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 261
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K972009.
ULTRALON POWDER FREE LATEX SURGICAL GLOVE
K973699 · Johnson & Johnson Medical, Inc. · Dec 1997
ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
K973461 · Ansell Perry · Dec 1997
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
K972621 · Wembley Rubber Products (M) Sdn Bhd · Oct 1997
POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES
K971381 · Allegiance Healthcare Corp. · Jul 1997
EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS)
K964440 · Maxxim Medical · Apr 1997
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
K964474 · Allegiance Healthcare Corp. · Mar 1997