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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K052177
Device Name POWDER FREE STERILE LATEX SURGICAL GLOVES
Applicant
Hartalega Sdn Bhd
9 Jalan Kuang Bulan Taman
Kepong Industrial Estate
Kuala Lumpur,  MY 52100
Applicant Contact NURUL AISYAH KONG
Correspondent
Hartalega Sdn Bhd
9 Jalan Kuang Bulan Taman
Kepong Industrial Estate
Kuala Lumpur,  MY 52100
Correspondent Contact NURUL AISYAH KONG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/10/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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