FDA 510(k) Application Details - K113749

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K113749
Device Name	Vinyl Patient Examination Glove
Applicant	FULL SYNERGY MEDICAL PRODUCTS INC 5748 EAGLEWOOD PLACE RANCHO CUCAMONGA, CA 91739 US Other 510(k) Applications for this Company
Contact	ELIZABETH DENG Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2011
Decision Date	03/15/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review