FDA 510(k) Application Details - K220055

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K220055
Device Name	Vinyl Patient Examination Glove
Applicant	Dezhou Hengchang Medical Technology Co., Ltd West Side of South Tiandingfeng Road, Xingtong Sub-district Office, Linyi County, Dezhou City 251500 CN Other 510(k) Applications for this Company
Contact	Jing Li 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	01/06/2022
Decision Date	08/25/2022
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