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FDA 510(k) Application Details - K203030
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K203030
Device Name
Surgeon'S Gloves
Applicant
WRP ASIA PACIFIC SDN BHD
Lot 1 Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi
Sepang 43900 MY
Other 510(k) Applications for this Company
Contact
Saravanan Ramasamy
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
10/02/2020
Decision Date
06/11/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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