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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 K893767
Device Name DISPOSABLE LATEX EXAMINATION GLOVES
Applicant
MASIF HEALTHCARE PRODUCTS SDN. BHD.
wisma taiko, no. 1, jalan s.p.
seenivasagam
ipoh, perak,  MY 30000
Applicant Contact see khek
Correspondent
MASIF HEALTHCARE PRODUCTS SDN. BHD.
wisma taiko, no. 1, jalan s.p.
seenivasagam
ipoh, perak,  MY 30000
Correspodent Contact see khek
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/19/1989
Decision Date 09/19/1989
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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