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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 K010663
Device Name POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE
Applicant
Tong Ruhn Medical Products Co., Ltd.
1202 S. Rte 31
Mc Henry,  IL  60050
Applicant Contact ANTONIO L GIACCIO
Correspondent
Tong Ruhn Medical Products Co., Ltd.
1202 S. Rte 31
Mc Henry,  IL  60050
Correspondent Contact ANTONIO L GIACCIO
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/06/2001
Decision Date 03/30/2001
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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