Cleared Traditional

K160928 - Latex Polymer Coated Powder Free Surgic...

K160928 is an FDA 510(k) clearance for Latex Polymer Coated Powder Free Surgic..., manufactured by Hartalega Sdb. Bhd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K160928 · Hartalega Sdb. Bhd. · General Hospital
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Dec 2016
Decision
260d
Days
Class 1
Risk

K160928 is an FDA 510(k) clearance for the Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim o.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Hartalega Sdb. Bhd. (Bandar Sri Damansara, MY). The FDA issued a Cleared decision on December 20, 2016 after a review of 260 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 Hartalega Sdb. Bhd. devices

FDA 510(k) Submission Details - K160928

510(k) Number K160928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2016
Decision Date December 20, 2016
Days to Decision 260 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 129d · This submission: 260d
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 K160928.
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
K170198 · Cardinal Health, Inc. · Jun 2017
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
K170152 · Hartalega Sdn Bhd · May 2017
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
K161823 · Wrp Asia Pacific Sdn. Bhd. · Jan 2017
Gammex Cut-Resistant Glove Liner
K160974 · Ansell Healthcare Products, LLC · Oct 2016
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
K161008 · Hartalega Sdn Bhd · Jul 2016
Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
K160875 · Cardinal Health, Inc. · Jul 2016