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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 K131823
Device Name PROPRIETARY / DONGTAI/ OTHER CLIENTS PRIVATE LABELING
Applicant
DONG TAI CITY HUAYI GLOVES CO., LTD.
RM 1606 BLDG, 1 JIAN XIANG YUAN NO. 209
BEI SI HUAN ZHONG RD HAI DI
BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
DONG TAI CITY HUAYI GLOVES CO., LTD.
RM 1606 BLDG, 1 JIAN XIANG YUAN NO. 209
BEI SI HUAN ZHONG RD HAI DI
BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/20/2013
Decision Date 12/09/2013
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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