FDA 510(k) Application Details - K093516

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K093516
Device Name	Polymer Patient Examination Glove
Applicant	SUMMIT GLOVE, INC. 310 SOUTH GRANT ST. MINERVA, OH 44657 US Other 510(k) Applications for this Company
Contact	JAMES MOORE 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	06/29/2010
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