Cleared Traditional

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K200181 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Apr 2020
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K200181 is an FDA 510(k) clearance for the Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, 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 April 15, 2020, 82 days after receiving the submission on January 24, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K200181 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2020
Decision Date April 15, 2020
Days to Decision 82 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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