FDA 510(k) Application Details - K220228

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K220228
Device Name	Polymer Patient Examination Glove
Applicant	Shandong Blue Sail Health Technology Co., Ltd No. 1888 Langgao Road, Langshan Advanced Technology Industrial Park Weifang 262600 CN Other 510(k) Applications for this Company
Contact	Shi Haifeng 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	01/27/2022
Decision Date	03/18/2022
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