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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 K895322
Device Name LATEX EXAMINATION GLOVES
Applicant
Advantage Resources
Suite 6.09, 6th Floor
Jalan Imbi Imbi Plz.
Kuala Lumpur Malaysia,  MY 55100
Applicant Contact ANDY GOH
Correspondent
Advantage Resources
Suite 6.09, 6th Floor
Jalan Imbi Imbi Plz.
Kuala Lumpur Malaysia,  MY 55100
Correspondent Contact ANDY GOH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/29/1989
Decision Date 12/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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