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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 K170136
Device Name Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
Applicant
Shandong Feiyang Professional Gloves Co., Ltd.
338 Huaqing Dr.
Qixin Chemical Industry Zone
Qingzhou,  CN 255000
Applicant Contact KEN LU
Correspondent
Basic Medical Industries., Inc.
805 Barrington Ave.
Ontario,  CA  91764
Correspondent Contact XIAOFEI HAO
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received01/17/2017
Decision Date 08/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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