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FDA 510(k) Application Details - K183280
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K183280
Device Name
Polymer Patient Examination Glove
Applicant
Smart Glove Corporation Sdn. Bhd.
Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar
Klang 42100 MY
Other 510(k) Applications for this Company
Contact
Khon Pu Foo
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
11/23/2018
Decision Date
07/26/2019
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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