FDA 510(k) Application Details - K050154

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K050154
Device Name	Vinyl Patient Examination Glove
Applicant	ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD. UNIT 707, AVIC BLDG. NO 10B, CENTRAL RD, E RING RD, CHAOYANG DISTRICT; BEIJING 100022 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	01/24/2005
Decision Date	02/07/2005
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