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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 K142190
Device Name Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs
Applicant
Pt. Medisafe Technologies
Ji Bantang Kuis. Gg Tambak Rejo Pasar Ix, Desa Buntu Bedimar
Tanjung Morawa, Medan,  ID 20362
Applicant Contact Anil Taneja
Correspondent
Pt. Medisafe Technologies
Ji Bantang Kuis. Gg Tambak Rejo Pasar Ix, Desa Buntu Bedimar
Tanjung Morawa, Medan,  ID 20362
Correspondent Contact Anil Taneja
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received08/08/2014
Decision Date 07/14/2015
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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