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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 K983816
Device Name NITRILE LATEX POWDERED EXAMINATION GLOVE
Applicant
Top Glove Sdn. Bhd.
41050 Klang,Selangor
Darul Ehsan,  MY
Applicant Contact T.S. PUON
Correspondent
Top Glove Sdn. Bhd.
41050 Klang,Selangor
Darul Ehsan,  MY
Correspondent Contact T.S. PUON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/29/1998
Decision Date 12/04/1998
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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