Cleared Traditional

K151824 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (FDA 510(k) Clearance)

Class I General Hospital device.

K151824 · Kossan International Sdn Bhd · General Hospital

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Aug 2016

Decision

393d

Days

Class 1

Risk

K151824 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kossan International Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on August 2, 2016 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number	K151824 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 06, 2015
Decision Date	August 02, 2016
Days to Decision	393 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

265d slower than avg

Panel avg: 128d · This submission: 393d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LZA Polymer Patient Examination Glove
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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.