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FDA 510(k) Application Details - K982274
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K982274
Device Name
Polymer Patient Examination Glove
Applicant
ASIA PACIFIC LATEX SDN BHD
14, JALAN TAIPING
KUALA KANGSAR, PERAK 33000 MY
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Contact
LEE SOON HONG
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
06/29/1998
Decision Date
08/11/1998
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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