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FDA 510(k) Application Details - K203512
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K203512
Device Name
Polymer Patient Examination Glove
Applicant
VIP Glove SDN BHD
No 17, Jalan Perusahaan 1, Kawasan Perusahaan Beranang
Beranang 43700 MY
Other 510(k) Applications for this Company
Contact
Terence Lim
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
11/30/2020
Decision Date
04/26/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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