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FDA 510(k) Application Details - K192635
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K192635
Device Name
Polymer Patient Examination Glove
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
Hasnah Abdul Hamid
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
09/23/2019
Decision Date
01/17/2020
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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