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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 K173258
Device Name Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
Applicant
Pt. Medisafe Technologies
J1 Batang Kuis, Gg Tambak Rejo
Pasar IX, Desa Buntu Bedimbar, Kecamatan Tanjung Morawa
Medan,  ID 20362
Applicant Contact Deepak Bang
Correspondent
Pt. Medisafe Technologies
J1 Batang Kuis, Gg Tambak Rejo
Pasar IX, Desa Buntu Bedimbar, Kecamatan Tanjung Morawa
Medan,  ID 20362
Correspondent Contact Deepak Bang
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received10/10/2017
Decision Date 04/20/2018
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
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