FDA 510(k) Application Details - K220491

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K220491
Device Name	Patient Examination Glove, Specialty
Applicant	Hainan Asther Medical Equipment Co., Ltd 503 Room, 5th Floor, B03, Hainan Ecological Software Park, Old Town Chengmai 571900 CN Other 510(k) Applications for this Company
Contact	Viki Ye 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	02/22/2022
Decision Date	05/14/2022
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