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FDA 510(k) Application Details - K993386
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K993386
Device Name
Latex Patient Examination Glove
Applicant
GREAT GLOVE SDN BHD
24, JALAN RAJA MOKHTAR DUA
KAPAR, SELANGOR D.E. 42200 MY
Other 510(k) Applications for this Company
Contact
K.M. LEE
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
10/08/1999
Decision Date
12/20/1999
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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