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FDA 510(k) Application Details - K021521
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K021521
Device Name
Latex Patient Examination Glove
Applicant
SMART GLOVE CORP. SDN BHD
LOT 6487 BATU 5 3/4
JALAN KAPAR
KLANG SELANGOR 42100 MY
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Contact
NG YEW SOON
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
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More FDA Info for this Product Code
Date Received
05/10/2002
Decision Date
07/02/2002
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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