FDA 510(k) Application Details - K980149

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K980149
Device Name	Polymer Patient Examination Glove
Applicant	MASJU SDN. BHD. PLOT 3, JALAN 1, TIKAM BATU SUNGAI PETANI 08600 MY Other 510(k) Applications for this Company
Contact	HENG CHENG HUI 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	01/16/1998
Decision Date	01/29/1998
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	Y
Expedited Review