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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 K103337
Device Name MULTIPLE NAME
Applicant
Ideal Quality Sdn., Bhd.
Lot 2796, 17 1/2 Miles
Jalan Kapar
Klang,  MY 42200
Applicant Contact SH TAN
Correspondent
Ideal Quality Sdn., Bhd.
Lot 2796, 17 1/2 Miles
Jalan Kapar
Klang,  MY 42200
Correspondent Contact SH TAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/15/2010
Decision Date 02/25/2011
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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