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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K892413
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
BEIJING JIAN XING LATEX PRODUCTS CO., LTD.
14, JIAO MEN, MAJIA PU
FENG TAI DISTRICT
BEIJING, CHINA,  CN
Applicant Contact XIN MIN
Correspondent
BEIJING JIAN XING LATEX PRODUCTS CO., LTD.
14, JIAO MEN, MAJIA PU
FENG TAI DISTRICT
BEIJING, CHINA,  CN
Correspondent Contact XIN MIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 08/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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