FDA 510(k) Application Details - K220353

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K220353
Device Name	Patient Examination Glove, Specialty
Applicant	Niujian Technology Co., Ltd Room 401, Building 1, Anfangcheng, No.919, East Qunxian Road Yuecheng District Shaoxing 312030 CN Other 510(k) Applications for this Company
Contact	Alan Chow Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2022
Decision Date	03/31/2022
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