FDA 510(k) Application Details - K991457

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K991457
Device Name	Vinyl Patient Examination Glove
Applicant	SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. #1 BIYU RD.,CANGQIAO TOWNSHIP SONGJIANG COUNTY SHANGHAI CN Other 510(k) Applications for this Company
Contact	DANNY 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	04/26/1999
Decision Date	07/01/1999
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