FDA 510(k) Application Details - K112741

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K112741
Device Name	Vinyl Patient Examination Glove
Applicant	LIFESTYLE SAFTY PRODUCTS (HUI ZHOU) CO. LTD MEDICAL DEVICE & DRUG DEVISION 144 RESEARCH DRIVE HAMPTON, VA 23666 US Other 510(k) Applications for this Company
Contact	RHONDA T ALEXANDER 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	09/21/2011
Decision Date	09/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review