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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 K011012
Device Name POWDER FREE NITRILE EXAMINATION GLOVE
Applicant
Contract Latex Dippers Sdn Bhd
Lot 5b, 7a & 8a Fasa 2
Kawasan Miel
Batang Kali, Selangor,  MY 44300
Applicant Contact VINAYAGAN RAMALINGAM
Correspondent
Contract Latex Dippers Sdn Bhd
Lot 5b, 7a & 8a Fasa 2
Kawasan Miel
Batang Kali, Selangor,  MY 44300
Correspondent Contact VINAYAGAN RAMALINGAM
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/04/2001
Decision Date 05/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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