FDA 510(k) Application Details - K220343

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K220343
Device Name	Polymer Patient Examination Glove
Applicant	NB Medical Co., LTD Tay An Industrial Cluster, Tien Hai Town Tien Hai district, Thai Binh Province, Vietnam Thai Binh Province 410000 VN Other 510(k) Applications for this Company
Contact	Kecheng Zhou 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	02/07/2022
Decision Date	04/02/2022
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