FDA 510(k) Application Details - K980093

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K980093
Device Name	Vinyl Patient Examination Glove
Applicant	UNIVERSAL GLOVES CORP. 10 SHIN JIUNN RD., SHIN YING INDUSTRIAL ZONE, SHIN YING, TAINAN HSIEN 730 TW Other 510(k) Applications for this Company
Contact	JOHN CHEN 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	01/09/1998
Decision Date	03/02/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review