FDA 510(k) Application Details - K060030

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K060030
Device Name	Surgeon'S Gloves
Applicant	BIOBARRIER, INC. 367 PLEASANT VALLEY RD. P.O. BOX 39 GOOD HOPE, GA 30641 US Other 510(k) Applications for this Company
Contact	DAVID W MULLIS Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2006
Decision Date	06/27/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review