FDA 510(k) Application Details - K991304

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K991304
Device Name	Polymer Patient Examination Glove
Applicant	M.R.G. INDUSTRIES SDN. BHD. PT. 4004, JALAN PERUSAHAAN 3 KAMUNTING INDU. ESTATE, BOX 9 KAMUNTING, PERAK 34600 MY Other 510(k) Applications for this Company
Contact	CHONG ENG LIM Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/1999
Decision Date	06/23/1999
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