Cleared Traditional

K141579 - EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE (FDA 510(k) Clearance)

Class I General Hospital device.

K141579 · Eco Medi Glove Sdn. Bhd. · General Hospital

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Oct 2014

Decision

126d

Days

Class 1

Risk

K141579 is an FDA 510(k) clearance for the EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Eco Medi Glove Sdn. Bhd. (Kamunting Perak, MY). The FDA issued a Cleared decision on October 17, 2014 after a review of 126 days - within the typical 510(k) review window.

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. 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 Eco Medi Glove Sdn. Bhd. devices

Submission Details

510(k) Number	K141579 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 13, 2014
Decision Date	October 17, 2014
Days to Decision	126 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

2d faster than avg

Panel avg: 128d · This submission: 126d

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.