FDA 510(k) Application Details - K152720

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K152720
Device Name	Polymer Patient Examination Glove
Applicant	XINGDA MEDICAL PRODUCTS CO., LTD. SOUTH OF SHENGZHUANG VILLAGE, LUANNAN COUNTY TANGSHAN 063502 CN Other 510(k) Applications for this Company
Contact	ZHANG LIXIA 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	09/21/2015
Decision Date	03/10/2016
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