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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 K983568
Device Name OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
Applicant
Contract Latex Dippers Sdn Bhd
# 11-2nd Floor Jalan 7/70a
Sri Hartamas
Kuala Lumpur,  MY 50480
Applicant Contact VINAYAGAN RAMALINGAM
Correspondent
Contract Latex Dippers Sdn Bhd
# 11-2nd Floor Jalan 7/70a
Sri Hartamas
Kuala Lumpur,  MY 50480
Correspondent Contact VINAYAGAN RAMALINGAM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/13/1998
Decision Date 12/21/1998
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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