Cleared Traditional

K150414 - Midas Touch-Nitrile Examination Gloves-...

Also marketed or referenced as:
Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL

K150414 is an FDA 510(k) clearance for Midas Touch-Nitrile Examination Gloves-..., manufactured by Industrial Clothings (Pvt), Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K150414 · Industrial Clothings (Pvt), Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
114d
Days
Class 1
Risk

K150414 is an FDA 510(k) clearance for the Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Industrial Clothings (Pvt), Ltd. (Avissawella, LK). The FDA issued a Cleared decision on June 12, 2015 after a review of 114 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 Industrial Clothings (Pvt), Ltd. devices

FDA 510(k) Submission Details - K150414

510(k) Number K150414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date June 12, 2015
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
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 750
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K150414.
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
K151684 · Hartalega NGC Sdn. Bhd. · Sep 2015
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
K151343 · Hartalega NGC Sdn. Bhd. · Aug 2015
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
K143289 · Yty Industry (Manjung) Sdn Bhd · Aug 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K150593 · Hartalega Sdn Bhd · Jun 2015
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
K150103 · Hartalega Sdn Bhd · Apr 2015
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
K150110 · Hartalega NGC Sdn. Bhd. · Apr 2015