FDA 510(k) Application Details - K221143

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K221143
Device Name	Polymer Patient Examination Glove
Applicant	Hebei Astro Medical Supply Co., Ltd. East of Xiaoxixian, West of Jingsan Street, South of Weiwu Road, North of Weiqi Road, Jinzhou Eco Jinzhou 052260 CN Other 510(k) Applications for this Company
Contact	Ning Zheng 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	04/20/2022
Decision Date	08/25/2022
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