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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K020359
Device Name ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES
Applicant
Ar Alliance Healthcare Sdn. Bhd.
8, Lorong Industri 11, Kawasan
Perindustrian Bukit Panchor,
Nibong Tebal, Pulau Pinang,  MY 14300
Applicant Contact CHUA CHOON CHUAN
Correspondent
Ar Alliance Healthcare Sdn. Bhd.
8, Lorong Industri 11, Kawasan
Perindustrian Bukit Panchor,
Nibong Tebal, Pulau Pinang,  MY 14300
Correspondent Contact CHUA CHOON CHUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/04/2002
Decision Date 03/06/2002
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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