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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K102074
Device Name POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
Applicant
Gx Corporation Sdn Bhd
Lot 6487a, Batu 5 3/4, Sementa
Jalan Kapar
Klang, Selang Darul Ehsan,  MY 42100
Applicant Contact CHO S FONG
Correspondent
Gx Corporation Sdn Bhd
Lot 6487a, Batu 5 3/4, Sementa
Jalan Kapar
Klang, Selang Darul Ehsan,  MY 42100
Correspondent Contact CHO S FONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/26/2010
Decision Date 11/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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