Cleared Traditional

K143131 - Powder Free Nitrile Patient Examination...

K143131 is an FDA 510(k) clearance for Powder Free Nitrile Patient Examination..., manufactured by Kossan International Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K143131 · Kossan International Sdn Bhd · General Hospital
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Feb 2015
Decision
104d
Days
Class 1
Risk

K143131 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile. 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 February 12, 2015 after a review of 104 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 Kossan International Sdn Bhd devices

FDA 510(k) Submission Details - K143131

510(k) Number K143131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2014
Decision Date February 12, 2015
Days to Decision 104 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
25d faster than avg
Panel avg: 129d · This submission: 104d
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 K143131.
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
Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla
K143055 · Yty Industry (Manjung) Sdn Bhd · Feb 2015
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
K142685 · Siam Sempermed Corp., Ltd. · Feb 2015
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
K142283 · Yty Industry (Manjung) Sdn Bhd · Jan 2015
Nitrile Powder Free Examination Glove (Blue)
K142588 · Hartalega Sdn Bhd · Dec 2014