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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 K963441
Device Name BALDUR VINYL POWDERED GLOVES
Applicant
Hti Trading Group
3423 Investment Blvd.
Suite 12
Hayward,  CA  94545
Applicant Contact DAVID HU
Correspondent
Hti Trading Group
3423 Investment Blvd.
Suite 12
Hayward,  CA  94545
Correspondent Contact DAVID HU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/30/1996
Decision Date 02/14/1997
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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