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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 K010628
Device Name POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
Applicant
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD.
12390 EAST END AVE.
CHINO,  CA  91710
Applicant Contact JAMES CHU
Correspondent
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD.
12390 EAST END AVE.
CHINO,  CA  91710
Correspondent Contact JAMES CHU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/02/2001
Decision Date 04/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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