FDA 510(k) Application Details - K151682

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K151682
Device Name	Vinyl Patient Examination Glove
Applicant	Daxwell, LLC 2825 Wilcrest Dr., Suite #500 Houston, TX 77042 US Other 510(k) Applications for this Company
Contact	Frank Zhang 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	06/22/2015
Decision Date	11/17/2015
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	N
Expedited Review