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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 K133699
Device Name POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
Applicant
Pt. Smartglove Indonesia
Jl. Pelita Rauya # 5-7,Kim Star,
Tanjung Morawa
Medan, North Sumater,  ID 20362
Applicant Contact KHON PU FOO
Correspondent
Pt. Smartglove Indonesia
Jl. Pelita Rauya # 5-7,Kim Star,
Tanjung Morawa
Medan, North Sumater,  ID 20362
Correspondent Contact KHON PU FOO
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/03/2013
Decision Date 07/18/2014
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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