FDA 510(k) Application Details - K003922

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K003922
Device Name	Polymer Patient Examination Glove
Applicant	GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK 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	12/20/2000
Decision Date	02/15/2001
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