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FDA 510(k) Application Details - K193581
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K193581
Device Name
Polymer Patient Examination Glove
Applicant
Sri Trang Gloves (Thailand) Public Company Limited
10 SOi 10 Phetkasem Road
Hatyai 90110 TH
Other 510(k) Applications for this Company
Contact
Jarinya Jirojkul
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
12/23/2019
Decision Date
03/20/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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