FDA 510(k) Application Details - K963514

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K963514
Device Name	Vinyl Patient Examination Glove
Applicant	SHANGHAI PM PLASTICS ENTERISE CO., LTD. NO. 258,W.YUSHU RD.& S.HU-HANG RAILWAY, CANGQIAO TOWNSHIP SONGJIANG CO., SHANGHAI CN Other 510(k) Applications for this Company
Contact	CHANG TE SUN 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	09/03/1996
Decision Date	10/24/1996
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