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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 K983645
Device Name SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
Applicant
Shijiazhuang Great Eagle Plastic Products Co., Ltd.
13945 Magnolia Ave.
Chino,  CA  91710
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Shijiazhuang Great Eagle Plastic Products Co., Ltd.
13945 Magnolia Ave.
Chino,  CA  91710
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/16/1998
Decision Date 12/04/1998
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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