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FDA 510(k) Application Details - K021058
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K021058
Device Name
Latex Patient Examination Glove
Applicant
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
NO. 1 FANJIAZHUNG INDUSTRIAL
ZONE
XINJI CITY, HEBEI PROVINCE 052360 CN
Other 510(k) Applications for this Company
Contact
TAN SWU CHOON
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
04/02/2002
Decision Date
05/14/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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