FDA 510(k) Application Details - K213548

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K213548
Device Name	Polymer Patient Examination Glove
Applicant	Mercator Medical (Thailand) LTD 88/8 Moo 12 Tambon Kampaengphet Amphur Rattaphum 90180 TH Other 510(k) Applications for this Company
Contact	Praneet Inthajak 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	11/08/2021
Decision Date	02/21/2022
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