Cleared Traditional

NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK

K151836 · Hartalega NGC Sdn. Bhd. · General Hospital
Oct 2015
Decision
107d
Days
Class 1
Risk

About This 510(k) Submission

K151836 is an FDA 510(k) clearance for the NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on October 21, 2015, 107 days after receiving the submission on July 6, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K151836 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2015
Decision Date October 21, 2015
Days to Decision 107 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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