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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 K891443
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
SUKAS SDN BHD
KILANG NO. 1, AMPANG RAILWAY
JALAN PASAR OFF JALAN BESAR
68000 AMPANG, S.D.E. WEST,  MY
Applicant Contact S. K FONG
Correspondent
SUKAS SDN BHD
KILANG NO. 1, AMPANG RAILWAY
JALAN PASAR OFF JALAN BESAR
68000 AMPANG, S.D.E. WEST,  MY
Correspondent Contact S. K FONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/15/1989
Decision Date 03/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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