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FDA 510(k) Application Details - K080937
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K080937
Device Name
Polymer Patient Examination Glove
Applicant
GX CORPORATION SDN BHD
LOT 6487A, BATU 5 3/4, SEMENTA
JALAN KAPAR
KLANG 42100 MY
Other 510(k) Applications for this Company
Contact
FOO K PU
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
04/02/2008
Decision Date
05/23/2008
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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