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FDA 510(k) Application Details - K120066
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K120066
Device Name
Polymer Patient Examination Glove
Applicant
KOSSAN LATEX INDUSTRIES(M)SDN BHD
LOT 6129,JALAN HAJI ABDUL
MANAN, OFF JALAN MERU
KLANG, SELANGOR D.E. 41050 MY
Other 510(k) Applications for this Company
Contact
CHO S FONG
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
01/09/2012
Decision Date
11/16/2012
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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