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FDA 510(k) Application Details - K983568
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K983568
Device Name
Latex Patient Examination Glove
Applicant
CONTRACT LATEX DIPPERS SDN BHD
NO. 11-2ND FL. JALAN 7/70A
SRI HARTAMAS
KUALA LUMPUR 50480 MY
Other 510(k) Applications for this Company
Contact
VINAYAGAN RAMALINGAM
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
10/13/1998
Decision Date
12/21/1998
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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