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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 K982218
Device Name NITRILE POWDER-FREE UNISEAL GLOVES
Applicant
American Healthcare Products (M) Sdn Bhd
Pt 7521 Taman Semarak Ii
Light Industrial Park
Nilai, Negeri Sembilan 71800,  MY 71800
Applicant Contact TARANI DEVI
Correspondent
American Healthcare Products (M) Sdn Bhd
Pt 7521 Taman Semarak Ii
Light Industrial Park
Nilai, Negeri Sembilan 71800,  MY 71800
Correspondent Contact TARANI DEVI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/24/1998
Decision Date 11/30/1998
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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