FDA 510(k) Application Details - K011593

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K011593
Device Name	Polymer Patient Examination Glove
Applicant	ANSELL HEALTHCARE PRODUCTS, INC. 1875 HARSH AVENUE, S.E. MASSILLON, OH 44646-7199 US Other 510(k) Applications for this Company
Contact	JAMES R CHATTERTON 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	05/24/2001
Decision Date	06/21/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review