FDA 510(k) Application Details - K142858

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K142858
Device Name	Polymer Patient Examination Glove
Applicant	Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban Negeri Sembilan Darul Khusus 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	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2014
Decision Date	02/09/2015
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