FDA 510(k) Application Details - K121992

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K121992
Device Name	Polymer Patient Examination Glove
Applicant	XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., 12390 EAST END 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	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2012
Decision Date	10/16/2012
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