FDA 510(k) Application Details - K220834

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K220834
Device Name	Polymer Patient Examination Glove
Applicant	DAXWELL, LLC 2825 Wilcrest Dr #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	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2022
Decision Date	06/29/2022
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