FDA 510(k) Application Details - K101565

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K101565
Device Name	Vinyl Patient Examination Glove
Applicant	ZIBIO YINGJIE MEDICAL PRODUCTS CO., LTD 12390 EAST AVE. CHINO, CA 91710 US Other 510(k) Applications for this Company
Contact	FRANK LIU 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	06/04/2010
Decision Date	08/17/2010
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