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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 K994206
Device Name SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
Applicant
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
NO. 135 XIN-HUA WEST ROAD
SHIJIAZHUANG CITY
HEBEI PROVINCE,  CN 050081
Applicant Contact GUI-XI LIU
Correspondent
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
NO. 135 XIN-HUA WEST ROAD
SHIJIAZHUANG CITY
HEBEI PROVINCE,  CN 050081
Correspondent Contact GUI-XI LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/14/1999
Decision Date 02/07/2000
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
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