FDA 510(k) Application Details - K223214

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K223214
Device Name	Polymer Patient Examination Glove
Applicant	Global Protection Corp. 12 Channel Street Boston, MA 02210 US Other 510(k) Applications for this Company
Contact	Christina Cataldo 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	10/17/2022
Decision Date	09/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review