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FDA 510(k) Application Details - K122377
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K122377
Device Name
Vinyl Patient Examination Glove
Applicant
SHU TONG XINGHUA CO., LTD.
WEST OF XI HUAN ROAD
ECONOMIC DEVELOPMENT DISTRICT
XINGHUA 225700 CN
Other 510(k) Applications for this Company
Contact
SU SONG SHI
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2012
Decision Date
04/11/2014
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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