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FDA 510(k) Application Details - K090520
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K090520
Device Name
Vinyl Patient Examination Glove
Applicant
SHANDONG HUAYUE GLOVE CO., LTD.
EAST OF YIFAN/NORTH OF NAQI RD
ZHANGDIAN, SHANDONG CN
Other 510(k) Applications for this Company
Contact
JINYOU LIN
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
02/26/2009
Decision Date
05/18/2009
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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