Cleared Traditional

COMFORT RUBBER GLOVES IND.SDN.BHD.

K101917 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Oct 2010
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K101917 is an FDA 510(k) clearance for the COMFORT RUBBER GLOVES IND.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 October 29, 2010, 112 days after receiving the submission on July 9, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K101917 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2010
Decision Date October 29, 2010
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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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