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510(k) Premarket Notification

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Device Classification Name glove, patient examination, latex
510(k) NumberK935980
Model POWDERED AND POWDER FREE
Device NameCIR LATEX GLOVES (CIR GOLD SEAL)
Applicant
CROCKER INDUSTRIAL RESOURCES SDN. BHD.
plo 38, senai industrial area,
phase 2
senai, johor, 
Contactchong l chuan
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/13/1993
Decision Date 05/02/1994
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Statement/Summary/Purged Status Statement only
Type Traditional
Reviewed by Third Party No
Expedited Review
 
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