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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 K091652
Device Name NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
Applicant
Hartalega Sdn Bhd
# 7 Kawasan Perusahaan Suria
Bestari Jaya,  MY 45600
Applicant Contact NURUL AISYAH KONG BT ABDULLAH
Correspondent
Hartalega Sdn Bhd
# 7 Kawasan Perusahaan Suria
Bestari Jaya,  MY 45600
Correspondent Contact NURUL AISYAH KONG BT ABDULLAH
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received06/09/2009
Decision Date 09/04/2009
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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