FDA 510(k) Application Details - K211457

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K211457
Device Name	Polymer Patient Examination Glove
Applicant	Ammex Corporation 1019 W James St, Suite 200 Kent, WA 98032 US Other 510(k) Applications for this Company
Contact	Sasitharan Nair 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	05/11/2021
Decision Date	12/18/2021
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