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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 K100421
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
TANGSHAN YONKSHUN GLOVE, CO., LTD
rom 1606 bldg 1 jianxiang
yuan no. 209, bei si huan
zho, beijing,  CN 100083
Applicant Contact chu xiaoan
Correspondent
TANGSHAN YONKSHUN GLOVE, CO., LTD
rom 1606 bldg 1 jianxiang
yuan no. 209, bei si huan
zho, beijing,  CN 100083
Correspondent Contact chu xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/16/2010
Decision Date 09/27/2010
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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