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FDA 510(k) Application Details - K050214
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K050214
Device Name
Polymer Patient Examination Glove
Applicant
HARTALEGA SDN BHD
LOT 9, JALAN KUANG BULAN,TAMAN
KEPONG IND. ESTATE
SELANGOR, DARUL EHSAN 52100 MY
Other 510(k) Applications for this Company
Contact
KUAN EU JIN
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
01/31/2005
Decision Date
03/16/2005
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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