FDA 510(k) Application Details - K121529

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K121529
Device Name	Polymer Patient Examination Glove
Applicant	NORTHSTAR HEALTHCARE HOLDINGS HAMILTON HOUSE, 10 QUEEN ST HAMILTON, BERMUDA HM11 IE Other 510(k) Applications for this Company
Contact	WESLEY TOAVS 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	05/24/2012
Decision Date	07/12/2012
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	Y
Expedited Review