FDA 510(k) Application Details - K000867

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K000867
Device Name	Latex Patient Examination Glove
Applicant	SGMP CO., LTD. 181 MOO 6, TAMBOL KAMPAENGPETCH, RATTAPHUM SONGKHLA 90180 TH Other 510(k) Applications for this Company
Contact	CHEAH CHOR HEE 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	03/17/2000
Decision Date	04/21/2000
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