FDA 510(k) Application Details - K053259

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K053259
Device Name	Vinyl Patient Examination Glove
Applicant	PRACTICAL PROTECTIVE PLASTIC MANUFACTORY LTD. 1800 CENTURY PARK EAST SUITE 600 CENTURY CITY, CA 90067 US Other 510(k) Applications for this Company
Contact	GEORGE SU Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2005
Decision Date	01/18/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review