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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 K062655
Device Name POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
Applicant
Shijiazhuang Junfei Plastic Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Applicant Contact KATHY LIU
Correspondent
Shijiazhuang Junfei Plastic Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact KATHY LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/07/2006
Decision Date 09/18/2006
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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