FDA 510(k) Application Details - K141304

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K141304
Device Name	Polymer Patient Examination Glove
Applicant	YONGXIN HEALTHCARE CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS BEIJING 100083 CN Other 510(k) Applications for this Company
Contact	CHU XIAOAN 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	05/19/2014
Decision Date	12/12/2014
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