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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 K011883
Device Name POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
Applicant
Shijiazhuang Eversharp Plastic Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact JAMES CHU
Correspondent
Shijiazhuang Eversharp Plastic Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact JAMES CHU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/18/2001
Decision Date 07/17/2001
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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