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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K102189
Device Name POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
Applicant
Latexx Manufacturing Sdn.Bhd.
11925 W 1-70 Frontage Rd. N.
Suite 900
Wheat Ridge,  CO  80033
Applicant Contact NEIL BURRIS
Correspondent
Latexx Manufacturing Sdn.Bhd.
11925 W 1-70 Frontage Rd. N.
Suite 900
Wheat Ridge,  CO  80033
Correspondent Contact NEIL BURRIS
Regulation Number880.6250
Classification Product Code
LZC  
Date Received08/02/2010
Decision Date 03/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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