FDA 510(k) Application Details - K162858

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K162858
Device Name	Patient Examination Glove, Specialty
Applicant	Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate SEREMBAN 70450 MY Other 510(k) Applications for this Company
Contact	LIM KWEE SHYAN Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/2016
Decision Date	07/24/2017
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