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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K053259
Device Name DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
Applicant
Practical Protective Plastic Manufactory , Ltd.
1800 Century Park E. Suite 600
Los Angeles,  CA  90067
Applicant Contact GEORGE SU
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact LAURA DANIELSON
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/22/2005
Decision Date 01/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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