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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 K891507
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Purna Bina Sdn Bhd
7.5km Jalan Mersing
Kluang Industrial Area, Kluang
Johor,  MY 86000
Applicant Contact SIEW HOCK
Correspondent
Purna Bina Sdn Bhd
7.5km Jalan Mersing
Kluang Industrial Area, Kluang
Johor,  MY 86000
Correspondent Contact SIEW HOCK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/1989
Decision Date 04/06/1989
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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