FDA 510(k) Application Details - K063810

Device Classification Name	Powder-Free Guayle Rubber Examination Glove   More FDA Info for this Device
510(K) Number	K063810
Device Name	Powder-Free Guayle Rubber Examination Glove
Applicant	YULEX CORPORATION 37860 W SMITH-ENKE RD MARICOPA, AZ 85239 US Other 510(k) Applications for this Company
Contact	KATRINA CORNISH Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	OIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2006
Decision Date	04/18/2008
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