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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 K142409
Device Name Vinyl Co-Polymer Powder Free Examination Gloves
Applicant
GRAND WORK PLASTIC PRODUCTS CO., LTD.
DONGGAO INDUSTRIAL ZONE ZANHUANG
ZANHUANG COUNTY,  CN 050000
Applicant Contact DENG ZHANYONG
Correspondent
HONGRAY USA MEDICAL PRODUCTS INC
3973 SCHAEFER AVE.
CHINO,  CA  91710
Correspondent Contact KATHY LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/27/2014
Decision Date 12/05/2014
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
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