Cleared Traditional

COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

K974424 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Apr 1998
Decision
150d
Days
Class 1
Risk

About This 510(k) Submission

K974424 is an FDA 510(k) clearance for the COMFORT RUBBER GLOVES INDUSTRIES SDN BHD, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on April 23, 1998, 150 days after receiving the submission on November 24, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K974424 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1997
Decision Date April 23, 1998
Days to Decision 150 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LYY — Latex Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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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