FDA 510(k) Application Details - K133689

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K133689
Device Name	Polymer Patient Examination Glove
Applicant	PT. MEDISAFE TECHNOLOGIES JL.BATANG KUIS GG.TAMBAK REJO DESA BUNTU BEDIMBAR TJ. MORAWA MEDAN, NORTH SUMATERA 20362 ID Other 510(k) Applications for this Company
Contact	ANIL TANEJA 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	12/02/2013
Decision Date	07/03/2014
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