FDA 510(k) Application Details - K212485

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K212485
Device Name	Polymer Patient Examination Glove
Applicant	Fujian Yuanxin Safety Protection Technology Co., Ltd. Xiacun Medical Industry Zone, Zherong County Ningde 355300 CN Other 510(k) Applications for this Company
Contact	Alan Wu 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	08/09/2021
Decision Date	11/05/2021
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