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FDA 510(k) Application Details - K151390
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K151390
Device Name
Patient Examination Glove, Specialty
Applicant
MAXTER GLOVE MANUFACTURING SDN BHD
LOT 6070, JALAN HAJI ABDUL MANAH, 6TH MILES OFF JALAN MERU.
KLANG 41050 MY
Other 510(k) Applications for this Company
Contact
YAP PEAK GEEH
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/26/2015
Decision Date
05/02/2016
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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