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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K042567
Device Name POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E
Applicant
Pt. Medisafe Technologies
Jl.Batang Kuis Gg. Tambak Rejo
Desa Buntu Bedimbar Tj. Morawa
Medan, North Sumatra,  ID 20362
Applicant Contact ANIL TANEJA
Correspondent
Pt. Medisafe Technologies
Jl.Batang Kuis Gg. Tambak Rejo
Desa Buntu Bedimbar Tj. Morawa
Medan, North Sumatra,  ID 20362
Correspondent Contact ANIL TANEJA
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/21/2004
Decision Date 01/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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