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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact