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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 K120746
Device Name DISPOSABLE POWDER FREE VINYL EXAM GLOVES
Original Applicant
CANOPUS MEDICAL SUPPLY CO., LTD.
18709 green bat dr.,
rowland highs,  CA  91748
Original Contact gloria chang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/12/2012
Decision Date 04/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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