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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 K992922
Device Name SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
Applicant
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
NO. 135 XIN-HUA WEST RD.
SHIJIAZHUANG,  CN 050081
Applicant Contact GUI-XI LIU
Correspondent
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
NO. 135 XIN-HUA WEST RD.
SHIJIAZHUANG,  CN 050081
Correspondent Contact GUI-XI LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/30/1999
Decision Date 10/06/1999
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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