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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K123760
Device Name MULTIPLE NAME
Applicant
Assurguard Sdn. Bhd.
82f, Jalan Pulasan
Klang
Selangor Darul Ehsan,  MY 41000
Applicant Contact LIM HUI GUAN
Correspondent
Assurguard Sdn. Bhd.
82f, Jalan Pulasan
Klang
Selangor Darul Ehsan,  MY 41000
Correspondent Contact LIM HUI GUAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/07/2012
Decision Date 01/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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