Cleared Traditional

K970160 - UNIJECT SURGICAL GLOVES

K970160 is an FDA 510(k) clearance for UNIJECT SURGICAL GLOVES, manufactured by Uniject Gloves , Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K970160 · Uniject Gloves , Ltd. · General Hospital
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Jul 1997
Decision
180d
Days
Class 1
Risk

K970160 is an FDA 510(k) clearance for the UNIJECT SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Uniject Gloves , Ltd. (Chalmette, US). The FDA issued a Cleared decision on July 15, 1997 after a review of 180 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 Uniject Gloves , Ltd. devices

FDA 510(k) Submission Details - K970160

510(k) Number K970160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1997
Decision Date July 15, 1997
Days to Decision 180 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
51d slower than avg
Panel avg: 129d · This submission: 180d
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 282
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K970160.
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
K972621 · Wembley Rubber Products (M) Sdn Bhd · Oct 1997
DIGIFLEX SURGICAL GLOVES
K972277 · Hms Services, Inc. · Oct 1997
PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE
K972009 · Tillotson Healthcare Corp. · Sep 1997
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE
K971945 · Tillotson Healthcare Corp. · Jul 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