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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 K971356
Device Name POWDER FREE SYNTHETIC EXAMINATION GLOVES
Applicant
Arista Latindo Industrial Ltd. P.T
128 Jalan Kyai Haji Muhammad
Mansyur
Jakarta Barat,  ID 11210
Applicant Contact LINGA SUMARTA
Correspondent
Arista Latindo Industrial Ltd. P.T
128 Jalan Kyai Haji Muhammad
Mansyur
Jakarta Barat,  ID 11210
Correspondent Contact LINGA SUMARTA
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/11/1997
Decision Date 09/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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