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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 K123368
Device Name LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
Applicant
Hartalega Sdn Bhd
# 7 Kawasan Perusahaan Suria
Bestari Jaya,  MY 45600
Applicant Contact NURUL AISYAH KONG
Correspondent
Hartalega Sdn Bhd
# 7 Kawasan Perusahaan Suria
Bestari Jaya,  MY 45600
Correspondent Contact NURUL AISYAH KONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/01/2012
Decision Date 05/07/2013
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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