FDA 510(k) Application Details - K981979

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K981979
Device Name	Latex Patient Examination Glove
Applicant	AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD PT 7521 TAMAN SEMARAK II LIGHT INDUSTRIAL PARK NILAI, NEGERI SEMBILAN 71800 71800 MY Other 510(k) Applications for this Company
Contact	TARANI DEVI 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	06/05/1998
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