FDA 510(k) Application Details - K082690

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K082690
Device Name	Vinyl Patient Examination Glove
Applicant	HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN, NO 209, BEI SI HUAN ZHONG ROAD; 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	09/15/2008
Decision Date	02/09/2009
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