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FDA 510(k) Application Details - K210249
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K210249
Device Name
Polymer Patient Examination Glove
Applicant
Bestsafe Glove CO., LTD
52/43 Wat Khot Hin-Khao Phai Road, Tubma
Muang Rayong 21000 TH
Other 510(k) Applications for this Company
Contact
Piyawat Chirasakulkarun
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
01/29/2021
Decision Date
10/25/2021
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
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