FDA 510(k) Application Details - K963441

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K963441
Device Name	Vinyl Patient Examination Glove
Applicant	HTI TRADING GROUP 3423 INVESTMENT BLVD. SUITE 12 HAYWARD, CA 94545 US Other 510(k) Applications for this Company
Contact	DAVID HU 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	08/30/1996
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