FDA 510(k) Application Details - K010719

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K010719
Device Name	Polymer Patient Examination Glove
Applicant	PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT OFF JALAN KAPAR, PO BOX 188 SELANGOR DARUL EHSAN 41720 MY Other 510(k) Applications for this Company
Contact	KONG C TAN 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	03/12/2001
Decision Date	04/10/2001
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