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FDA 510(k) Application Details - K992223
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K992223
Device Name
Polymer Patient Examination Glove
Applicant
PAMITEX INDUSTRIES SDN BHD
2 1/2 MILES, JALAN RASAH
SEREMBAN, NAGERI SEMBILAN
DARUL KHUSUS 70300 MY
Other 510(k) Applications for this Company
Contact
SAID AWANG
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/01/1999
Decision Date
08/30/1999
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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