FDA 510(k) Application Details - K093523

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K093523
Device Name	Polymer Patient Examination Glove
Applicant	ANSELL HEALTHCARE PRODUCTS LLC 1635 INDUSTRIAL RD. DOTHAN, AL 36303 US Other 510(k) Applications for this Company
Contact	CYNTHIA A INGRAM 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	11/13/2009
Decision Date	03/04/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review