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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 K133689
Device Name POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
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 Number880.6250
Classification Product Code
LZA  
Date Received12/02/2013
Decision Date 07/03/2014
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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