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FDA 510(k) Application Details - K102880
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K102880
Device Name
Polymer Patient Examination Glove
Applicant
BRIGHTWAY HOLDINGS SDN. BHD.
LOT 1559, JALAN ISTIMEWA,
BATU BELAH
KLANG, SELANGOR 42100 MY
Other 510(k) Applications for this Company
Contact
NADARAJAN VENUGOPAL
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
09/30/2010
Decision Date
11/19/2010
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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