FDA 510(k) Application Details - K211586

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K211586
Device Name	Polymer Patient Examination Glove
Applicant	Lyncmed Medical Technology (Beijing) Co., Ltd. Room 1601, Building No. 2, Zhubang 2000 Business Building, Balizhuangxili 99, Chaoyang District Beijing 100022 CN Other 510(k) Applications for this Company
Contact	Jiali Zhou 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	05/24/2021
Decision Date	11/01/2021
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