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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 K173580
Device Name Vinyl Patient Examination Glove (Yellow)
Applicant
Nature Medical Products Co., Ltd.
#7 W. St., Sigezhuang Town
Bencheng,  CN 063000
Applicant Contact Chao Kevin
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
5-402, Bldg. #27, # 56, Liangxiang E. Rd.,
Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/20/2017
Decision Date 02/15/2018
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
Predetermined Change
Control Plan Authorized		 No
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