FDA 510(k) Application Details - K011749

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K011749
Device Name	Latex Patient Examination Glove
Applicant	SEMPERMED USA, INC. 30798 US HWY. 19 NORTH PALM HARBOR, FL 34684 US Other 510(k) Applications for this Company
Contact	KATIE LEVINSON Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2001
Decision Date	08/22/2001
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