Cleared Traditional

K141579 - EMG BLACK NITRILE MEDICAL EXAMINATION G...

K141579 is an FDA 510(k) clearance for EMG BLACK NITRILE MEDICAL EXAMINATION G..., manufactured by Eco Medi Glove Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K141579 · Eco Medi Glove Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K141579

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
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

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.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 683
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K141579.
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NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
K140890 · Hartalega NGC Sdn. Bhd. · Jul 2014