FDA 510(k) Application Details - K964800

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K964800
Device Name	Vinyl Patient Examination Glove
Applicant	SHANGHAI JIAWANG INDUSTRIAL CO. LTD. NO.3 ZHU HANG CHEN EAST JINSHAN DISTRICT SHANGHAI CITY, SHANGHAI 201506 CN Other 510(k) Applications for this Company
Contact	CHRISTINE GALEA 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	11/29/1996
Decision Date	02/14/1997
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