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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 K101351
Device Name NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT
Applicant
ASCEND EAGLE, INC.
198 AVE DE LA DEMERALD
SPARKS,  NV  94589
Applicant Contact JANNA P TUCKER
Correspondent
ASCEND EAGLE, INC.
198 AVE DE LA DEMERALD
SPARKS,  NV  94589
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/14/2010
Decision Date 10/15/2010
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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