FDA 510(k) Application Details - K221192

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K221192
Device Name	Polymer Patient Examination Glove
Applicant	Shandong Maida Medical Technology Co.,Ltd. Room 102, Eastern building, No.166 South 1st Road, Development zone Dongying 257000 CN Other 510(k) Applications for this Company
Contact	Kitty Xu 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	04/25/2022
Decision Date	06/22/2022
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