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FDA 510(k) Application Details - K992810
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K992810
Device Name
Latex Patient Examination Glove
Applicant
HWA TEH INDUSTRIAL SDN. BHD.
LOT 187, SUNGAI DAHAR
BATANG BERJUNTAI 45600 MY
Other 510(k) Applications for this Company
Contact
K. KARUNAKARAN
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
08/20/1999
Decision Date
09/27/1999
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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