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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 K050215
Device Name NITRILE POWDERED EXAMINATION GLOVES (WHITE)
Applicant
Hartalega Sdn Bhd
Lot 9, Jalan Kuang Bulan,Taman
Kepong Ind. Estate
Selangor, Darul Ehsan,  MY 52100
Applicant Contact KUAN EU JIN
Correspondent
Hartalega Sdn Bhd
Lot 9, Jalan Kuang Bulan,Taman
Kepong Ind. Estate
Selangor, Darul Ehsan,  MY 52100
Correspondent Contact KUAN EU JIN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/31/2005
Decision Date 03/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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