FDA 510(k) Application Details - K123469

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K123469
Device Name	Polymer Patient Examination Glove
Applicant	WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II LOT 63616, PT 54924, NO 3, JALAN KORPORAT 7C/KU9 TAMAN PERINDUSTRIAN MERU MUKIM KAPAR, KLANG, SELANGOR 42200 MY Other 510(k) Applications for this Company
Contact	ALEX YOONG 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	11/13/2012
Decision Date	02/19/2013
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