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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 K993722
Device Name BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.
Applicant
Hartalega Sdn Bhd
9 Jln Kanan,Kepong Garden
Industr Estate
Kuala Lumpur, 52100,  MY
Applicant Contact KUAN KAM HON
Correspondent
Hartalega Sdn Bhd
9 Jln Kanan,Kepong Garden
Industr Estate
Kuala Lumpur, 52100,  MY
Correspondent Contact KUAN KAM HON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/03/1999
Decision Date 11/23/1999
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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