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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 K150110
Device Name Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
Applicant
Hartalega NGC Sdn. Bhd.
Kawasan Perindustrian Tanjung, Jalan B20
Sepang,  MY 64000
Applicant Contact Kuan Mun Leong
Correspondent
Hartalega NGC Sdn. Bhd.
Dataran Sd Pju9
Bandar Sri Damansara,  MY 52200
Correspondent Contact Nurul Aisyah Kong
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/20/2015
Decision Date 04/23/2015
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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