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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 K892588
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Dynamic Plantations Sdn Bhd
2, Jalan 52/4, 46200 Petaling
Jaya, Selangor Darul Ehsan
Malaysia,  MY
Applicant Contact KENG SENG
Correspondent
Dynamic Plantations Sdn Bhd
2, Jalan 52/4, 46200 Petaling
Jaya, Selangor Darul Ehsan
Malaysia,  MY
Correspondent Contact KENG SENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 07/14/1989
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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