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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 K042239
Device Name FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
Applicant
Pt. Mandiri Inti Buana
Jalan Sei Belumai
Desa Dalu 10 A Dusun 1
Tanjung Morawa, Sumut,  ID 20362
Applicant Contact P. SASITHARAN NAIR
Correspondent
Pt. Mandiri Inti Buana
Jalan Sei Belumai
Desa Dalu 10 A Dusun 1
Tanjung Morawa, Sumut,  ID 20362
Correspondent Contact P. SASITHARAN NAIR
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/18/2004
Decision Date 12/16/2004
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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