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FDA 510(k) Application Details - K231973
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K231973
Device Name
Surgeon'S Gloves
Applicant
Ineo Tech Sdn Bhd
PT5825, Jalan Cassia Selatan 3/11 Taman Perindustrian
Batu Kawan
Bandar Kassia 14110 MY
Other 510(k) Applications for this Company
Contact
Pierre Hoerner
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/03/2023
Decision Date
09/29/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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