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FDA 510(k) Application Details - K033530
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K033530
Device Name
Latex Patient Examination Glove
Applicant
ASIA PACIFIC LATEX SDN BHD
LOT 12, MEDAN TASEK,
TASEK INDUSTRIAL ESTATE
IPOH PERAK 31400 MY
Other 510(k) Applications for this Company
Contact
LEE SON HONG
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/10/2003
Decision Date
01/28/2004
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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