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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 K142342
Device Name NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Applicant
Nacrous Plastic Co., Ltd.
Xibaipo Industry Park, Pingsham County
Shijiazhuang,  CN 050000
Applicant Contact WANG LI
Correspondent
Chu Xiaoan
Rm. 1606 Bldg. 1. Jianxiang Yuan # 209
Bei Si Huan Zhong Rd., Haidian Dis
Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/21/2014
Decision Date 12/18/2014
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
Predetermined Change
Control Plan Authorized		 No
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