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FDA 510(k) Application Details - K092617
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K092617
Device Name
Polymer Patient Examination Glove
Applicant
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
6324 MEETING HOUSE WAY
ALEXANDRIA, VA 22312-1718 US
Other 510(k) Applications for this Company
Contact
KOK-KEE HON
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
08/26/2009
Decision Date
05/20/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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