FDA 510(k) Application Details - K123819

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K123819
Device Name	Latex Patient Examination Glove
Applicant	TOP CALIBRE SDN BHD 1-1,2 JALAN SETIA PRIMA U13/S SETIA ALAM, SEKSYEN U13 SHAH ALAM, SELANGOR 40170 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	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2012
Decision Date	03/05/2013
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