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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K014077
Device Name POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
Applicant
Shijiazhuang Great Vision Plastic Products Co., LT
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact JAMES CHU
Correspondent
Shijiazhuang Great Vision Plastic Products Co., LT
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact JAMES CHU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/11/2001
Decision Date 02/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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