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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 K041913
Device Name POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
Applicant
Pt. Medisafe Technologies
Gg. Tambak Rejo
Desa Buntu Bedimbar
Tanjung Morawa, Medan,  ID 20362
Applicant Contact ANIL TANEJA
Correspondent
Pt. Medisafe Technologies
Gg. Tambak Rejo
Desa Buntu Bedimbar
Tanjung Morawa, Medan,  ID 20362
Correspondent Contact ANIL TANEJA
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/15/2004
Decision Date 12/01/2004
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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