FDA 510(k) Application Details - K213910

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K213910
Device Name	Patient Examination Glove, Specialty
Applicant	Changzhou Universal Medical Equipment Co. Ltd No. 6, Xinxi Road, Xinbei District Changzhou 213000 CN Other 510(k) Applications for this Company
Contact	Cai Jin Fu 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	12/15/2021
Decision Date	03/10/2022
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