FDA 510(k) Application Details - K243796

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K243796
Device Name	Polymer Patient Examination Glove
Applicant	Glove One, LLC 205 Raceway Dr Suite 3 Mooresville, NC 28117 US Other 510(k) Applications for this Company
Contact	Jason Palmer 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	12/10/2024
Decision Date	06/03/2025
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