FDA 510(k) Application Details - K043475

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K043475
Device Name	Vinyl Patient Examination Glove
Applicant	SHIJIAZHUANG WINFUL PLASTIC CO., LTD. NO. 10B CENTRAL ROAD, AVIC BLD EAST 3RD RING ROAD CHAOYANG DISTRICT, BEIJING 10002 CN Other 510(k) Applications for this Company
Contact	CHEN YUHONG 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	12/16/2004
Decision Date	02/01/2005
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