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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 K152692
Device Name Powder Free Vinyl Patient Examination Gloves (Green)
Applicant
Supermax Plastic Products Co., Ltd
314 Dragon River East Road
Shijiazhuang City,  CN 050000
Applicant Contact Wu Zhigang
Correspondent
HONGRAY USA MAEDICAL PRODUCTS INC
3973 SCHAEFER AVE.
CHINO,  CA  91710
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/21/2015
Decision Date 12/21/2015
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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