FDA 510(k) Application Details - K994276

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K994276
Device Name	Polymer Patient Examination Glove
Applicant	BIOPRO (M) SDN BHD LOT14, PT.4204 LINGKARN SULTN HISHAMUDDIN, NO. PRT. INDU. PORT KLANG 42000 MY Other 510(k) Applications for this Company
Contact	JAMES H LALE 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	12/20/1999
Decision Date	10/20/2000
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