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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 K992862
Device Name SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
Applicant
Shijiazhuang Great Vision Plastic Products Co., LT
13945 Magnolia Ave.
Chino,  CA  91710
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Shijiazhuang Great Vision Plastic Products Co., LT
13945 Magnolia Ave.
Chino,  CA  91710
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/25/1999
Decision Date 11/29/1999
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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