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FDA 510(k) Application Details - K202419
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K202419
Device Name
Polymer Patient Examination Glove
Applicant
TK Hitech Technology Co., Ltd.
1/221 Venish Irish Iris Watcharaphol Road
Tha Rang, Bangkok 10220 TH
Other 510(k) Applications for this Company
Contact
Kanyapadsanan Suppipatthipbodee
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
08/24/2020
Decision Date
04/16/2021
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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