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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K896759
Device Name PB PLUS LEAD LATEX GLOVES
Applicant
SISTEM MED-PRO (M) SDN BHD
5010 AVIATION BLVD., SUITE B
SANTA ROSA,  CA  95403
Applicant Contact ROBERT WEISS
Correspondent
SISTEM MED-PRO (M) SDN BHD
5010 AVIATION BLVD., SUITE B
SANTA ROSA,  CA  95403
Correspondent Contact ROBERT WEISS
Regulation Number880.6250
Classification Product Code
LZC  
Date Received12/01/1989
Decision Date 03/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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