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FDA 510(k) Application Details - K040828
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K040828
Device Name
Vinyl Patient Examination Glove
Applicant
ZIBO BORUI PLASTIC & RUBBER PRODUCTS CO., LTD.
17A STERLING ROAD
NORTH BILLERICA, MA 01862 US
Other 510(k) Applications for this Company
Contact
HUAN-CHUNG LI
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2004
Decision Date
04/19/2004
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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