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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 K022102
Device Name CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR
Applicant
Latexx Manufacturing Sdn.Bhd.
216 Charles St.
Hackensack,  NJ  07601
Applicant Contact LAW SIAU WOEI
Correspondent
Latexx Manufacturing Sdn.Bhd.
216 Charles St.
Hackensack,  NJ  07601
Correspondent Contact LAW SIAU WOEI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/28/2002
Decision Date 08/22/2002
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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