Cleared Traditional

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

K180476 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital

May 2018

Decision

82d

Days

Class 1

Risk

About This 510(k) Submission

K180476 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on May 15, 2018, 82 days after receiving the submission on February 22, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K180476 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2018
Decision Date	May 15, 2018
Days to Decision	82 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	LZC — Medical Glove, Specialty
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Disposable Medical Glove (examination Or Surgeon?s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.