Cleared Traditional

Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile

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

About This 510(k) Submission

K143131 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Kossan International Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on February 12, 2015, 104 days after receiving the submission on October 31, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K143131 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — 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.

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