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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 K161099
Device Name Powder Free Nitrile Examination Gloves, Black
Applicant
Pt. Maja Agung Latexindo
Jalan Utama # 98 Pujimulyo
Sunggal-Deli Serdang,  ID 20352
Applicant Contact IMELDA SHAMROCK
Correspondent
Shamrock Manufacturing Co., Inc.
5445 Daniels St.
Chino,  CA  91710
Correspondent Contact EMMY TJOENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/19/2016
Decision Date 02/23/2017
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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