FDA 510(k) Application Details - K231349

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K231349
Device Name	Polymer Patient Examination Glove
Applicant	Nephron Nitrile, LLC. 4777 12th Street Extension West Columbia, SC 29172 US Other 510(k) Applications for this Company
Contact	Lou Kennedy 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	05/09/2023
Decision Date	06/06/2023
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