FDA 510(k) Application Details - K130101

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K130101
Device Name	Vinyl Patient Examination Glove
Applicant	BYTECH DONGTAI CO., LTD. RM 1606 BUILDING 1 JIAN XIANG YUAN NO. 209 BEI SI HUAN ZHONG RD. HAI DI 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	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2013
Decision Date	11/08/2013
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