FDA 510(k) Application Details - K213019

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K213019
Device Name	Vinyl 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, Jinxhou 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	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2021
Decision Date	01/05/2022
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