FDA 510(k) Application Details - K982716

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K982716
Device Name	Latex Patient Examination Glove
Applicant	OMNIGRACE (THAILAND) LTD. 641 MOO 5 KANCHANAWANIT RD. TAMBON BANPRU HATYAI, SONGKHLA 90250 TH Other 510(k) Applications for this Company
Contact	K.C. CHOONG Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/1998
Decision Date	11/30/1998
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