FDA 510(k) Application Details - K001611

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K001611
Device Name	Vinyl Patient Examination Glove
Applicant	SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. NO. 268, YUSHU ROAD CANGQIAO TOWNSHIP SONGJIANG COUNTY SHANGHAI CN Other 510(k) Applications for this Company
Contact	PETER WANG 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	05/25/2000
Decision Date	06/30/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review