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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 K033531
Device Name POWDERED LATEX EXAMINATION GLOVES
Applicant
Apl International Incorporated Limited
Long Thanh District
Dong Nau Province
Dong Nau,  VN
Applicant Contact LEE SON HONG
Correspondent
Apl International Incorporated Limited
Long Thanh District
Dong Nau Province
Dong Nau,  VN
Correspondent Contact LEE SON HONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/10/2003
Decision Date 03/03/2004
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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