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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 K081315
Device Name POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)
Applicant
Gx Corporation Sdn Bhd
Lot 6487, Batu 5 3/4
Sementa, Jalan Kapar
Klang, Selangor,  MY 42100
Applicant Contact FOO K PU
Correspondent
Gx Corporation Sdn Bhd
Lot 6487, Batu 5 3/4
Sementa, Jalan Kapar
Klang, Selangor,  MY 42100
Correspondent Contact FOO K PU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/09/2008
Decision Date 08/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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