FDA 510(k) Application Details - K182575

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K182575
Device Name	Vinyl Patient Examination Glove
Applicant	Jiangxi Jaysun Medcare Co., Ltd. No.1 Jaysun Road, Penghuwan Industrial Park Pengze City, Jiujiang 332708 CN Other 510(k) Applications for this Company
Contact	Zong Run 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	09/19/2018
Decision Date	05/24/2019
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