Cleared Traditional

POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES

K110297 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Jun 2011
Decision
134d
Days
Class 1
Risk

About This 510(k) Submission

K110297 is an FDA 510(k) clearance for the POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES, 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 June 15, 2011, 134 days after receiving the submission on February 1, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K110297 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2011
Decision Date June 15, 2011
Days to Decision 134 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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