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FDA 510(k) Application Details - K161929
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K161929
Device Name
Polymer Patient Examination Glove
Applicant
Dipped Products (Thailand) Limited
82/2 MOO 9, Tumbon Rattapum
Amphur Khun Nieng 90220 TH
Other 510(k) Applications for this Company
Contact
Nilaksha Pushpakumara
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
07/14/2016
Decision Date
03/29/2017
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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