Cleared Traditional

EXAMINATION GLOVES

K140316 · Hl Rubber Industries Sdn Bhd · General Hospital
Jul 2014
Decision
151d
Days
Class 1
Risk

About This 510(k) Submission

K140316 is an FDA 510(k) clearance for the EXAMINATION GLOVES, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Hl Rubber Industries Sdn Bhd (Kuala Pilah, Negeri Sembilan, MY). The FDA issued a Cleared decision on July 11, 2014, 151 days after receiving the submission on February 10, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K140316 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2014
Decision Date July 11, 2014
Days to Decision 151 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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