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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 K891641
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Global Latex Products Sdn Bhd
Wisma Sama, Lot 26, Jalan
223/51a
Petaling Jaya Selang,  MY 46100
Applicant Contact KENG HUAT
Correspondent
Global Latex Products Sdn Bhd
Wisma Sama, Lot 26, Jalan
223/51a
Petaling Jaya Selang,  MY 46100
Correspondent Contact KENG HUAT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/17/1989
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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