Cleared Traditional

K140989 - POWDER FREE NITRILE SURGICAL GLOVES

K140989 is an FDA 510(k) clearance for POWDER FREE NITRILE SURGICAL GLOVES, manufactured by Hebei Hongsen Plastics Technology Co, Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K140989 · Hebei Hongsen Plastics Technology Co, Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2014
Decision
249d
Days
Class 1
Risk

K140989 is an FDA 510(k) clearance for the POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Hebei Hongsen Plastics Technology Co, Ltd. (New Milford, US). The FDA issued a Cleared decision on December 22, 2014 after a review of 249 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 Hebei Hongsen Plastics Technology Co, Ltd. devices

FDA 510(k) Submission Details - K140989

510(k) Number K140989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2014
Decision Date December 22, 2014
Days to Decision 249 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
120d slower than avg
Panel avg: 129d · This submission: 249d
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 272
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K140989.
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K121897 · Cardinal Health, Inc. · Jul 2012