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FDA 510(k) Application Details - K152715
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K152715
Device Name
Polymer Patient Examination Glove
Applicant
HAINING MEDICAL PRODUCTS CO., LTD
WEST OF DIANCHANG ROAD
LUANNAN COUNTY
TANGSHAN 063500 CN
Other 510(k) Applications for this Company
Contact
ZHANG LIANG
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
09/21/2015
Decision Date
02/25/2016
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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