FDA 510(k) Application Details - K991153

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K991153
Device Name	Latex Patient Examination Glove
Applicant	MEDTEXX INDUSTRIES (THAI) CO. LTD. 200 MU-4, TAMBOL TACHANG PO BOX 38 HATYAI AMPHUR BANGKLAM SONGKHLA 90110 TH Other 510(k) Applications for this Company
Contact	STEPHEN TAN CKENG KIM 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	04/06/1999
Decision Date	06/21/1999
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