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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 K053657
Device Name POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
Applicant
Pt Mahakarya Inti Buana
J1. Sei Belumai, Desa Dalu 10
A Dusun I # 18, Tanjung
Morawa, Sumut,  ID 20362
Applicant Contact P. SASITHARAN NAIR
Correspondent
Pt Mahakarya Inti Buana
J1. Sei Belumai, Desa Dalu 10
A Dusun I # 18, Tanjung
Morawa, Sumut,  ID 20362
Correspondent Contact P. SASITHARAN NAIR
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/05/2005
Decision Date 02/13/2006
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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