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FDA 510(k) Application Details - K072145
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K072145
Device Name
Latex Patient Examination Glove
Applicant
ZHANJIANG JIALI GLOVE PRODUCTS CO., LTD
SUITE 8D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD
SHANGHAI 200030 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2007
Decision Date
02/26/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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