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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 K983893
Device Name POWDERED VINYL EXAMINATION GLOVE
Applicant
Shijiazhuang Brethern Plastic Co., Ltd.
# 37 Zhonghua S. St.
Shijiazhuang, Hebei,  CN
Applicant Contact XIN-LAI ZHOU
Correspondent
Shijiazhuang Brethern Plastic Co., Ltd.
# 37 Zhonghua S. St.
Shijiazhuang, Hebei,  CN
Correspondent Contact XIN-LAI ZHOU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/02/1998
Decision Date 06/21/1999
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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