FDA 510(k) Application Details - K082457

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K082457
Device Name	Polymer Patient Examination Glove
Applicant	ANSELL HEALTHCARE PRODUCTS, INC. 1635 INDUSTRIAL ROAD 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	08/26/2008
Decision Date	11/10/2008
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