FDA 510(k) Application Details - K212148

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K212148
Device Name	Polymer Patient Examination Glove
Applicant	Ansell Healthcare Products LLC 2301 Robb Drive Reno, NV 89523 US Other 510(k) Applications for this Company
Contact	Donald Cronk 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	07/09/2021
Decision Date	03/10/2022
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