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FDA 510(k) Application Details - K220353
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K220353
Device Name
Patient Examination Glove, Specialty
Applicant
Niujian Technology Co., Ltd
Room 401, Building 1, Anfangcheng, No.919, East Qunxian Road
Yuecheng District
Shaoxing 312030 CN
Other 510(k) Applications for this Company
Contact
Alan Chow
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/08/2022
Decision Date
03/31/2022
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
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