FDA 510(k) Application Details - K221454

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K221454
Device Name	Polymer Patient Examination Glove
Applicant	Guangzhou Kangling Biotechnology Co., Ltd Baiyun Avenue,Yongping Street,Baiyun District,Guangzhou City East side of H Building,No. 10 E Guangzhou 510440 CN Other 510(k) Applications for this Company
Contact	Yan Wang 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	05/19/2022
Decision Date	07/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review