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FDA 510(k) Application Details - K142805
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K142805
Device Name
Polymer Patient Examination Glove
Applicant
HARTALEGA SDB. BHD.
DATARAN SD PJU9
BANDAR SRI DAMANSARA 52200 MY
Other 510(k) Applications for this Company
Contact
KUAN KAM HON
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
09/29/2014
Decision Date
12/18/2014
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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