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FDA 510(k) Application Details - K024216
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K024216
Device Name
Vinyl Patient Examination Glove
Applicant
TOP GLOVE (ZHANGJIAGANG) CO. LTD.
3, ZHANGJIAGANG XI TANG ROAD
XI ZHANG TOWN 215614 CN
Other 510(k) Applications for this Company
Contact
LIM WEE CHAI
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
12/23/2002
Decision Date
02/27/2003
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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