FDA 510(k) Application Details - K211336

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K211336
Device Name	Vinyl Patient Examination Glove
Applicant	Inner Mongolia Cureguard Medical Materials Co., Ltd. RM 408, Building 5, Block B of Business Science & Technology Center, Jining District Ulanqab 012000 CN Other 510(k) Applications for this Company
Contact	Guo Hua 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	05/03/2021
Decision Date	06/16/2021
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