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FDA 510(k) Application Details - K010231
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K010231
Device Name
Latex Patient Examination Glove
Applicant
JK GLOVES SDN. BHD.
LOT 26738 & 26740-K8 & P2
JALAN TEE TECK SA
SENAI, JOHOR 81400 MY
Other 510(k) Applications for this Company
Contact
TAI SAI LEONG
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
01/24/2001
Decision Date
02/09/2001
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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