FDA 510(k) Application Details - K211239

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K211239
Device Name	Vinyl Patient Examination Glove
Applicant	Jiangxi Shengda Medical Technology Co., Ltd. No.25 Factory, Wencheng Block, High-tech Zone, Yushan County Shangrao 334711 CN Other 510(k) Applications for this Company
Contact	Yun Gao 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	04/26/2021
Decision Date	07/17/2021
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