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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 K892981
Device Name PATIENT EXAMINATION GLOVES
Applicant
LAPOMA GLOVES INDUSTRIES SDN. BHD.
15-B, JALAN DEWANI, 81100
JOHOR BAHRU, NEGERI JOHOR
DARUL TAKZIM, MALAYSIA,  MY
Applicant Contact POH KIAT
Correspondent
LAPOMA GLOVES INDUSTRIES SDN. BHD.
15-B, JALAN DEWANI, 81100
JOHOR BAHRU, NEGERI JOHOR
DARUL TAKZIM, MALAYSIA,  MY
Correspondent Contact POH KIAT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 08/03/1989
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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