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FDA 510(k) Application Details - K040406
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K040406
Device Name
Latex Patient Examination Glove
Applicant
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS, NV 89434 US
Other 510(k) Applications for this Company
Contact
JANNA P TUCKER
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
02/17/2004
Decision Date
05/14/2004
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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