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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K093375
Device Name KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)
Applicant
Koon Seng Sdn Bhd
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/29/2009
Decision Date 12/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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