FDA 510(k) Application Details - K052845

Device Classification Name	Powdered Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K052845
Device Name	Powdered Latex Patient Examination Glove
Applicant	B-CARE INDUSTRIES CO., LTD. 13 RED FOX LANE LITTLETON, CO 80127 US Other 510(k) Applications for this Company
Contact	Kevin Walls Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	OPE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2005
Decision Date	12/16/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review