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FDA 510(k) Application Details - K123869
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K123869
Device Name
Polymer Patient Examination Glove
Applicant
DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD
12390 EAST END AVE.
CHINO, CA 91710 US
Other 510(k) Applications for this Company
Contact
RAY ZHOU
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/17/2012
Decision Date
02/28/2013
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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