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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 K143340
Device Name Powder Free Vinyl Patient Examination Gloves, Yellow Color
Applicant
Zibo Ling Yun Medical Products Co, Ltd.
# 318 Yuming Rd. Zibo Industrial Park
Zibo,  CN 255400
Applicant Contact Eric Wang
Correspondent
Basic Medical Industries., Inc.
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact RAY ZHOU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/21/2014
Decision Date 07/09/2015
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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