FDA 510(k) Application Details - K133949

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K133949
Device Name	Polymer Patient Examination Glove
Applicant	TOP CALIBRE SDN BHD Lot 13726, Jalan Haji Salleh, Batu 5 1/4 Off Jalan Meru KLANG, SELANGOR 41050 MY Other 510(k) Applications for this Company
Contact	ROSNITA MAODIN 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	12/23/2013
Decision Date	04/08/2014
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