FDA 510(k) Application Details - K062138

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K062138
Device Name	Polymer Patient Examination Glove
Applicant	MOLNLYCKE HEALTH CARE, INC. 5550 PEACHTREE PKWY STE 500 NORCROSS, GA 30092 US Other 510(k) Applications for this Company
Contact	STEVE DOWDLEY 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	07/26/2006
Decision Date	10/05/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review