FDA 510(k) Application Details - K130891

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K130891
Device Name	Vinyl Patient Examination Glove
Applicant	FRIEND PLASTIC CO., LTD. ROOM 1606 BLDG. 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DISTRICT BEIJING 050000 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	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2013
Decision Date	02/18/2014
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