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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K123757
Device Name POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR
Applicant
Assurguard Sdn. Bhd.
82f, Jalan Pulasan
Klang
Selangor Darul Ehsan,  MY 41000
Applicant Contact LIM H GUAN
Correspondent
Assurguard Sdn. Bhd.
82f, Jalan Pulasan
Klang
Selangor Darul Ehsan,  MY 41000
Correspondent Contact LIM H GUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/07/2012
Decision Date 02/01/2013
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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