FDA 510(k) Application Details - K220375

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K220375
Device Name	Polymer Patient Examination Glove
Applicant	Summit Glove, Inc 310 South Grant Street Minerva, OH 44657 US Other 510(k) Applications for this Company
Contact	James Hull 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	02/09/2022
Decision Date	04/13/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review