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FDA 510(k) Application Details - K221378
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K221378
Device Name
Polymer Patient Examination Glove
Applicant
Tec Gloves Industry (M) Sdn.Bhd.
Lot 35793, Jalan Sungai Batu 31/KU6, Kawasan Perindustrian
Klang Utama
Klang 42100 MY
Other 510(k) Applications for this Company
Contact
Eunice Arumugam
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
05/12/2022
Decision Date
09/30/2022
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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