FDA 510(k) Application Details - K984094

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K984094
Device Name	Vinyl Patient Examination Glove
Applicant	TRANS ANCIENT PRODUCTS CO., LTD. NO. 10-3, LANE 73, SEC. 2 CHUNG HUA EAST RD. TAINAN TW Other 510(k) Applications for this Company
Contact	JOANNA LEE 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	11/16/1998
Decision Date	01/14/1999
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