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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 K946021
Device Name VINYL POWDER-FREE EXAMINATION GLOVES
Applicant
Wilson Glove Products Co., Ltd.
P O Box 4223
Diamond Bar,  CA  91765
Applicant Contact NICHOLAS HUNG
Correspondent
Wilson Glove Products Co., Ltd.
P O Box 4223
Diamond Bar,  CA  91765
Correspondent Contact NICHOLAS HUNG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/09/1994
Decision Date 06/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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