Cleared Traditional

Powder Free Nitrile Examination Gloves (Orange)

K171541 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Sep 2017
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K171541 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (Orange), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on September 20, 2017, 117 days after receiving the submission on May 26, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K171541 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2017
Decision Date September 20, 2017
Days to Decision 117 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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