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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 K182156
Device Name Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Applicant
Syntex Healthcare Products Co., Ltd
No. 1, Fanjiazhuang, Industrial Zone, Xinji City, Hebei
Province China 052360
xinji city,  CN 052360
Applicant Contact qiao zhiqiang
Correspondent
Hongray USA Medical Products Inc
3973 Schaefer Avenue, Chino, CA 91810, USA
chino,  CA  91810
Correspondent Contact kathy liu
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received08/09/2018
Decision Date 12/10/2018
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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