FDA 510(k) Application Details - K120184

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K120184
Device Name	Polymer Patient Examination Glove
Applicant	ENCOMPASS MEDICAL SUPPLIES INC LIMITED HUA SHEN ROAD WAI GAO QIAO FREE ZONE SHANGHAI 200131 CN Other 510(k) Applications for this Company
Contact	CJ ANG 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	01/23/2012
Decision Date	05/02/2012
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